Incoming Regulatory Requests


      Global Regulatory has received the following incoming Regulatory Consulting Requests which need to be fulfilled ! These Regulatory Consulting Requests are received from a variety of sources ranging from large, multinational firms to industry organizations and government agencies actively seeking regulatory consulting services such as such as Regulatory Submissions, Audits, Compliance, Training, Quality Systems, Risk Analysis, Labeling Reviews, Government Relations, Regulatory Strategy Development, Expert Witnesses, Legal Reviews, Export/Import, etc.. If your company receives for Proposals that it can not fulfill, please refer them to us!

        Medical Devices manufacturer needs assistance with product registration and clinical studies ( read more )
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        Consulting needed on rquirements for setting up API plant for oncology medicines phase 3 in India ( read more )
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        Singapore nutraceutical company requires regulatory consulting for marketing authorization of nutraceuticals that contain herbal ingredients in any of the European Union states. ( read more )
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        Consultant needed to advise on GLP,NABL,GMP and how it is applied including to upgrading of diagnostic procedures. ( read more )
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        Cosmetics company needs consulting on regulatory position of cosmetic raw materials for different countries ( read more )
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        Consultant needed for Dossier preparations for regulated markets, certifications & Technical reviews ( read more )
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        Medical Device company needs GLP consultant on setting up a preclinical medical device laboratory for GLP compliance. ( read more )
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        Medical Device company needs consulting on it's first class II medical device 510k filing. ( read more )
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        Consultant needed to inspect three pharmaceutical manufacturing areas for cGMP compliance. Two locations in Huntsville, AL and One in Charlotte, NC ( read more )
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        Small start-up hair care company needs consulting help with labeling. ( read more )
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        Regulatory consulting services for drugs and biotech to assist a small specialty pharma company. ( read more )
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        Training courses in regulatory affairs geared towards the medical industry. ( read more )
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        Pharmaceutical e-marketing regulatory information on 19 countries-- beginning with Germany, Spain, UK. ( read more )
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        Independent consultant needed with at least 5 years experience in software/computer systems validation in a GMP environment, preferably medical device manufacturing. ( read more )
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        Consultant needed for development of EU- GMP system for pharmaceutical manufacturing facility. From Gap analysis till the achievement of EU-GMP. ( read more )
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        Consultant needed to conduct audits of clinical trial centres, TMF's ,related systems etc. to ICH GCP standards ( read more )
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        Disinfectant solution manufacturer wants to supply this product to Canada as a medical device. We want to claim the product sterile and will use a RABS to achieve class A in C environment and need to make the final decision on the classification on the authorities side. Need to determine whether it would be Health canada or would Health canada accept the classification from the Norwegian authorities or a notified body? ( read more )
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        IVD Medical Device and Novel Therapy System Manufacturer needs Consultant for advising on market entry requirements for medical device in Russia, India, Brazil, Mexico, Australia, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Taiwan, and Saudi Arabia. 2 types of medical device to look at i.e. an IVD device and a novel tumor therapy system. (detailed info available once replied) ( read more )
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        Medical Device Consultant needed who is familiar with medical device regulations in South Africa and who can assist in getting approval for registering and marketing there. ( read more )
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        Consultant needed for IVD consulting for a GLP/CE lab in Europe. ( read more )
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        Need information regarding setting up clinical trials in Romania. ( read more )
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        Bioanalytical laboratory looking to outsource Quality Assurance for their GLP studies. ( read more )
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        21 CFR Part 11 consultant needed for GAMP training & review of MES package to ensure it complys with 21CFRpart11. Would also like basic GAMP 4 training for 5 staff ( read more )
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        Agency in western part of India who can authorise and train us to acclaim DMF and MHRA certification for supply of packaging material co-extruded 3 layer poly film for packing of IV Solutions required for medical use. ( read more )
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        Consultant needed for Summary of the Product Characteristics for a veterinary medicine in Spain, Hungary, Slovakia, Poland, Romania, Czech Republic ( read more )
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        GMP consultant needed to support a Japanese company in cGMP regulations in preparation for a pre-approval inspection PAI ( read more )
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        Pharmaceutical Regulatory Consultant needed for consulting on a Drug Master Filing (the Cost and feasibility of filing DMF) ( read more )
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        Consultant needed for due dilligence in feasibility of conducting a Phase 3, oncology study in India, Japan, and Australia. ( read more )
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        Electronics manufacturer needs consultant to determine electronics compliance regulations to comply with South American countries standards. ( read more )
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        FDA Labeling consultant needed to review our product labeling and websites for FDA compliance. Advice on constructing space for an in-house packaging and labeling operation that will meet FDA requirements also. ( read more )
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        Validation consultant needed to validate a new steam sterilizer from IQ, OQ and PQ cycle runs. ( read more )
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        Large chemical manufacturer needs Quality Assurance QAU auditor for field efficacy studies of household insecticide products and personal or area repellents ( read more )
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        cGMP consulting for Quality Assurance and Quality Control of dietarry suppelemt (natural Health Products) ( read more )
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        Regulatory consultant experienced in ANDA's needed with strong CMC experience with liquid pharmaceuticals needed for several ANDA supplements and also a product transfer. This will be a 6-8 week full time assignment in our client's location. ( read more )
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        Multinational beverage manufacturer needs experienced consultant for advising on regulatory issues relating to functional beverages in world-wide markets. ( read more )
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        Consultants needed for assisting on the training and obtaining licenses for Biomedical Research auditing and Quality Assurance. ( read more )
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        Consultant needed for assistance on the specific EU requirements for biological products. ( read more )
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        Dental Instrument Distributor needs FDA and ISO 9001 consultant for consulting related to shipping issues with Korea. ( read more )
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        Validation consultant needed for software validation as per 21cfr standards. ( read more )
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        Regulatory consultant experienced with FDA importation of 10 animal drugs into the US needed. Spanish speaking consultant preferred. ( read more )
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        Antimicrobial fiber manufacturer needs legal or regulatory consultants experienced in medical devices regulations in Mexico. We are interested in selling protective and surgical clothing incorporating our antimicrobial technology in Mexico. The antimicrobial compound is approved for use as a fabric and fiber preservative in the US. ( read more )
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        Pharmaceuticals manufacturer needs consultant for consulting on Canadian regulatory requirements i.e Audit requirements, dossier requirements and others ( read more )
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        Food manufacturer needs consultant to register food products with UK Food Standards Agency. ( read more )
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        GLP consultant needed for setting up a preclinical medical device laboratory for GLP compliance ( read more )
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        We are seeking consultants who can help our clients better understand EU regulatory affairs environment, filing process and rulings (Biologics and Devices) and IP protection to our clients. Our clients are Institutional Investors such as hedge fund managers, Private Equity funds and Major Consultancy firms in US. ( read more )
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        Regulatory consultants needed for obtaining USFDA PMA for Implanable Pacemakers, Titanium Dental Implants . ( read more )
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        Consultant needed for providing GLP training to Biotechnology firm with molecular biology, microbiology, fermentation, chemical and enzymatic processing ( read more )
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        Full service Regulatory Consultant needed with expertise in orthopedic implants and a proven trackrecord of Medical Device product registration in Mexico. ( read more )
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        Spanish speaking GMP consultants needed for GMP manufacturing system development for in-vitro diagnostic manufacturing facility in Spain. Location is already CE approved for manufacturing in the EU. ( read more )
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        Regulatory consultant needed for advising on FDA CVM Drug Approval and Clinical Trial for cancer treatment for canines using a autologous cell based product ( read more )
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        Regulatory consultant needed for Class 1 Medical Device Technical File ( read more )
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        Fast growing Brazilian cosmetics company needs regulatory consultant for global cosmetic labeling requirements. Support also needed for product registration on markets where required. ( read more )
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        VERY REPUTABLE EUROPEAN PHARMACEUTICS MANUFACTURING CONSULTING COMPANY NEEDED FOR PROJECT IN MIDDLE EAST ( read more )
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        International company needs FDA consultancy for 510(k) registration of dentifrice containing Fluoride, Potassium nitrate and another active ingredient inducing growth of tooth-analog material ( read more )
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        UK INCI and UE regulatory consulting needed for labeling requirements and safety analysis of cosmetic products (hand wash, body wash, shave gel) for sale in the UK. ( read more )
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        Australia TGA regulatory consultant needed for labeling consulting and classisfication with particular experience in natural topical products with a hompeopathic active/s. ( read more )
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        Nutraceuticals company needs FDA GMP consultant for compliance consulting of manufacutring to USFDA GMP standards. ( read more )
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        Regulatory consultant needed to guide cGMP manufacturing, process qualification, process validation, virus clearance validation to meet USFDA requirements. ( read more )
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        Telecommunications company needed for assisting on setting up Wimax ISP including acquiring DOT spectrum license for radio-spectrum. ( read more )
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        UK regulatory consultant needed for consulting on licensing and importing of medical devices. ( read more )
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        Regulatory consultant needed for on-going review packaging labeling ingredients to ensure ingredient compliance with united states and canada regulations. ( read more )
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        Pharmaceuticals consultants needed for prepartion of guidelines for cGmp inspections in every area of pharmaceuticals such as production of every dosage form including sterile preparations and Quality control department ( read more )
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        East Asia US FDA GLP and cGMP consultants needed for consulting to CRO's and pharmaceutical companies. The consultants should be physically located in East Asia or be available to be in East Asia for an extended amount of time. ( read more )
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        Small bioanalytical CRO needs established FDA consultant for mock FDA inspection. BioA expertise a must. FDA ANDA work experience necessary. ( read more )
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        Regulatory consultant needed for Canada oncology New Drug Submission (NDS) NDS in TPD, Canada. ( read more )
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        Consultant needed for advising Dental Manufacturer on European registration processes for toothpaste with 1.1% neutral Sodium fluoride ( read more )
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        Consultant needed for advising on compilation of EU CTD Common Technical Document dossiers for vaccine/parenterals pharmaceuticals ( read more )
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        Consultant needed for preparation of pharmaceuticals product dossier in CTD format for drug registration in USA, UK & Japan ( read more )
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        Food supplement manufacturer needs European Union registration of food supplements, instant beverages suuch as coffee, tea, cereal, chocolate, personal and skincare products. ( read more )
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        Training on Method Validation as per FDA cGMP Good Manufacturing Practices and Calibration of Analytical Testing Equipment ( read more )
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        Pharmaceuticals manufacturer needs cGMP pharmaceutical regulatory consultant to prepare FDA pharmaceuticals ANDA for tablets and prepare facility for cGMP. ( read more )
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        Regulatory consultant experienced with combination products (medical devices/pharmaceuticals) approval process in the UK needed for providing outline of regulatory approval process. ( read more )
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        Larg manufacturer needs regulatory consultants for USA & Canada Cosmetics and Dietary Supplement registration, product assessments and Technological consultation. We need your consultancy in the product registration / approval for the marketing Ayurvedic Products in North American market (As per USFDA & Canada legislative). It is related to: A. Label : 1. Label copy matter to be checked, Claim & indication with in the permission of USFDA & Canada Legislative. 2. Whether label complies with the statutory requirement of the Authrotiy, like Name, expiry date, Font size, Barcode size, Caution, direction for use etc. B. Ingredients: Assessment of the ingredient list subject to their acceptance ( permissible limits), Colour, Preservatives Etc. C. Laboratory Testing: What is the statutory requirement for the import in term of parameter of test report ( pH, Fatty Acid, Microbiological test report). Please find enclose the copy of test report. D. Other statutory requirement for the import of the cosmetics in USA & Canada. Please let us know, did you handled any ayurvedic product in Past? ( read more )
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        Sponsor needs consultants for preparing Annual Product Reports, Product Renewals and post-approval submissions in CTD format ( read more )
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        Biologics regulatory consultants experienced with vaccines and cell culture processes needed to prepare submissions for several adenovector based veterinary vaccines. We are anticipating that our Regulatory and Process Development departments will not be able to assist us due to time constraints. We are looking for an organization/individual to assist in preparing the Regulatory and Process Development portions of the RFP. ( read more )
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        Expert pharmaceuticals consultant with specialization in sterile pharmaceuticals needed to provide opinion on pharmaceuticals with transdermal root of administration ( read more )
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        Clinical Trial Consultant needed for consulting on phase I, II, III and IV clinical trials in Cyprus, Israel, Botswana, Bahamas, Luxembourg, El Salvador, Jamaica, New Zealand, Turkey, Uruguay and Bulgaria: - import process: who initiates, timelines, process itself? - EC submission process: who submits, fees and payment modality, number of copies, start- and end of trial requirements, timelines, documents needed for submission, process itself? - HA submission process: who submits, fees and payment modality, number of copies, documents needed for submission, format of submission, start- and end of trial requirements, timelines? - What is the process for protocol amendments? - To whom should safety reporting be done? - What is the national regulation with regard to the provision of trial medication post trial? ( read more )
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        Consultant needed for approval of application to export bottled water to UK in complaince with the UK Food Standards Agency ( read more )
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        Pharmaceuticals Regulatory Consultant needed for assistance with EU Common Technical Document (EU CTD) and GMP ( read more )
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        Regulatory ocnsulting needed for obtaining US FDA and Health Canada approval for novel oral and topical nutraceutical/cosmeceutical. We have recently been awarded a US utility patent for the world's first fast acting water soluble sunscreen. We have completed one successful clinical trial and plan to go to market under FTC regulations. At the same time we wish to seek FDA approval for both an oral and topical form. ( read more )
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        Pharmaceuticals regulatory consultant wanted for US FDA ANDA approval of pharmaceutical tablets as well as preparation of GMP manufacturing facility. ( read more )
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        Manufacturers of pharmaceuticals hard gel capsules needs pharmaceutical regulatory consultant for european registration, auditing, and filing an EDMF for approval to market product in Europe. ( read more )
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        Pharmaceutical manufacturer needs a consulting firm that to assist in registering and licensing pharmaceutical products, preparing submissions and dossiers in multiple countries in Asia (Thailand,Vietnam,Malaysia, Indonesia, Cambodia, Myanmar), Middle East countries (UAE), South America and Africa ( read more )
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        Pharmaceutical regulatory consultants needed for assistance in compilation and filing of dossier submissions for registration of generic pharmaceuticals in Japan. Familiarity with Biostudies, English and prior experience in the given line is mandatory. ( read more )
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        Regulatory consultant needed to consult on labeling regulatory requirements on pharmaceuticals used in clinical trials /studies in Egypt ( read more )
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        South American exporter needs food regulatory consultants for exporting beverages and food products to USA. ( read more )
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        Clinical Consultant needed to advise on standards for immunological clinical trials for blood collection in paediatric populations after vaccination for immuno assay. Advising on standards in India. ( read more )
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        Pharmaceutical Regulatory Consultant needed for labeling reviews for pharmaceuticals products ( read more )
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        Regulatory consultant needed for assistance with Canada DIN and NHP product filing for items containing SPF ( read more )
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        Pharmaceuticals Manufacturer needs regulatory consulting for US FDA registration and preparation of ANDA. BA and BE inspections also required. ( read more )
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        Medical Device Regulatory Consultant needed for providing assistance for filing PMA of orthopedic bone cement. Consultant must be knowledgeable of new regulatory laws for medical devices in Japan and experienced with orthopedic product PMAs, respectively class IIb and III products. ( read more )
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        Regulatory consultant needed for advising on nutraceutical product submissions to the SSA and the importing information for nutraceuticals into Mexico ( read more )
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        Medical Device Manufacturer of active implantable devices seeks consultant to advise on regulatory approval process in Australia. ( read more )
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        Food Canning Establishment needs Food Regulatory Consultant to advice on FCE Application ( read more )
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        Medical Device regulatory and translation services needed for approval and guidance on OTC Oral Health Products. Translation into 17 EU official languages including allowable claims and required text is needed for OTC Oral Health products; paste/ fluoride floss sticks ( read more )
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        Regulatory consultant needed for consulting on importation regulations and labeling requirments for soy isoflavone tablets to Canada. ( read more )
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        Nutraceuticals manufacturer needs regulatory consultant for business, regulatory and compliance consulting for a water additive nutraceutical. Regulatory Consulting to include product registration, compliance issues, and product labeling. Business consulting to include business registration, business structure, distributor compensation, taxation issues and network marketing. ( read more )
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        Pharmaceutical manufacturer needs pharmaceutical regulatory consultant to guide them in US FDA audit and regulatory documentation matters. ( read more )
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        Biologicals company needs company to assist with the development of a GMP Biologicals manufacturing facility for production of biologicals in India. ( read more )
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        Chemical Industry Magazine needs regulatory consultant to write articles and or editorials about "Cosmetic Regulatory Issues." ( read more )
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        Regulatory consultant well versed in Nutraceutical and Drug GMP regulations appplicable to analytical testing (stability, characterization, raw materials, etc.)needed for gap assessment of laboratory seeking to provide services - speciality metals testing (ICP-MS, AA, etc.) and provide follow-up support and remediation. ( read more )
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        Cosmetics company needs regulatory consultant for global cosmetic labeling requirements on cosmetic products. ( read more )
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        Consumer Products company needs regulatory consultant for regulatory assistance with household cleaning products marketed in Japan. ( read more )
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        Regulatory consultant needed for assisting in e-Submissions across the globe including ANDA, NDA and BLS's. Also kindly let us know whether you have any tools to cater to the e-submissions for ANDA, NDA and BLS's. Earlier response will be appreciated. ( read more )
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        Regulatory consultant needed for preliminary consulting on documentation needed for FDA pharmaceutical New Drug Applications (NDA), EU Common Technical Documents (CTD), FDA GMP Audits for pharmaceutical and manufacturing facility in India. Contact is in New Jersey. ( read more )
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        Medical Devices Manufacturer needs ISO, FDA GMP Contract Sterilizer needed for gamma or e-beam sterlization of medical devices" ( read more )
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        Medical Device Manufacturer needs MDD 93/42 EEC training provided on-line 93/42 including essential requirements, & technical files training for Cls I & II Medical device Mfg. /Adm. personnel. Affordable, convenient, scalable (from basic to Lead auditor) and certification is desired. ( read more )
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        Large multinational cosmetics company needs regulatory consultant for preparation of EU dossier for cosmetics. ( read more )
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        Large, multinational chemical manufacturer needs regulatory consultant to interpret regulatory requirements or registration requirements for ingredients of cosmetics to be imported into and sold in Brazil and other Latin America countries. ( read more )
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        Regulatory Consultants needed for FDA validation of OTC (Over the counter) Homoeopathic Medicines . ( read more )
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        Medical Device FDA GMP consultants needed for plant design and set-up new of new medical device manufacturing plant. ( read more )
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        Life Sciences company needs Validation Consultant for FDA Validation of LIS Software ( read more )
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        Pharmaceutical Regulatory Consultant needed for pharmaceutical product registrations in Russia ( read more )
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        Pharmaceutical Regulatory Consultant needed for assistance in filing US FDA ANDA on one pharmaceutical product. ( read more )
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        Regulatory consultant fluent in Spanish needed for consulting on US FDA approval process for injectable veterinary drug products. ( read more )
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        Pharmaceuticals consultant needed to provided Good Manufacturing Practices cGMP regulatory training ( read more )
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        Regulatory consultants experienced with EU and US PMA needed for product development team (approximately 4-8 hours per week) to ensure compliance with US FDA PMA, and EU regulations. Person will transition to developing design dossier, Shonin, and PMA in 18+ months after successful clinical studies. ( read more )
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        Medical Device Manaufacturer needs experienced regulatory consultant needed, preferably that speaks Japanese, for completion of Shonin application under PAL requirements for a PTCA device at our parent company. ( read more )
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        Seasoned high level regulatory pharmaceuticals professional with expertise in parenterals, sustained release injectable dosage forms for development of NDA strategy and to assess : 1. Aseptic facility validation Docs for opinion on FDA acceptability 2. Analytical methods validation docs opinion as to FDA acceptability of revised validated methods methods previously deemed unacceptable by FDA 3. Strategic expert guidance for company regulatory approach for FDA contact and communication (district and division) for facility, methods and negotiating requirements for process approval and clinical trial protocol approach and acceptability. ( read more )
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        Medical Devices ISO, GLP, GMP, GCP Regulatory Consultants needed for Medical Device Evaluation for multiple medical devices and In-Vitro Diagnostics to Regulations -ISO, GLP, GMP and GCP. For Disposable devices, blood glucose meters, pregnancy test kits, latex gloves, sutures, catheters, dressings, needles, blood bags, reproductive devices etc ( read more )
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        Clinical Pharmaceuticals Regulatory Consultant needed for clinical research training in the area of quality assurance / auditing techniques / auditor. ( read more )
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        ISO Quality consultant needed for Lead Assessor training on ISO 13485:2003 and QSR 820 ( read more )
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        Multinational Medical Devices Manufacturer needs validation consultant for providing process validation training. ( read more )
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        Medical Device company in Israel needs consultant for internal, 1 day biocompatibility and sterilization (EO) training ( read more )
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        Consultant needed for consulting on nutraceutical labeling claims and whether some ingredients would be considered new under FDA guidelines. We have two products, one that stimulates stem cells and another that is anti-inflammatory ( read more )
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        Consultant with minimum 2 years experience with HPFBI inspection needed to establish a cGLP microbiology laboratory in Canada. ( read more )
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        Veterinary vaccines manufacturer would like consultant for design, layout, construction and validation of new vaccine production plant. ( read more )
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        Initial importer of herbal supplement needs consultant to provide advisory services and guidance on FDA requirements such as registration, testing, labeling, etc. ( read more )
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        Medical Device Regulatory Consultants needed to establish overall regulatory strategy including filing 510k with US FDA and setting up internal QSR for for a new disposable safety syringe medical product. ( read more )
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        Herbal cosmetics manufacturer with ISO & GMP Certification needs consultants for registration of products in European Union Countries. ( read more )
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        Vaccines and immuno-biologics manufacturer needs regulatory consultants for generation of regulatory submission data for method validations of biologicals ( read more )
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        Chicago Food company needs a consultant to assist the Scientific & Regulatory Affairs team in reviewing food labels for compliance with US regulations.Experience with confectionary products is desired. ( read more )
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        California Based nutraceutical manufacturer seeking regulatory consulting service for FDA/GMP compliance and labelling needs. ( read more )
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        Biological manufacturer (vaccines) needs consultants for providing FDA Good Manufacturing Practices (GMP) training ( read more )
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        Nutraceutical importing company needs regulatory consultants to comply with FDA regulations for importing natural dietary supplements manufactured in Peru ( read more )
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        Regulatory consultant needed for labeling compliance of Dermatological Insect Repellent Products that specifically repels mosquitos and deer ticks. This product is also an aerosol. This product is set to be harmonized for sale in the USA & Canada ( read more )
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        Biotechnology company needs regulatory consultant to develop internal pharmacovigilance training materials ( read more )
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        Medical Device manufacturer needs consultants to assist with FDA medical device registration and approval filings for medical tubing for IV solution bags and lay flat tube Consulting needed to guide us how to proceed further to register our new down-stream products from our approved FDA medical devices master file. ( read more )
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        Regulatory consultant needed to develop handbook for Training and Procedures for FDA Drug Safety Pharmacovigilance. ( read more )
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        GMP Pharmaceutical Regulatory Consultants needed to develop GMP training courses that are applicable to the countries outside of the US (Canadian and European regs mostly but Japan, etc. would be a bonus) for individual quality manager. ( read more )
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        USFDA regulatory consultant needed to provide guidance on USFDA regulation of Biologics and Vaccines ( read more )
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        Regulatory consultants needed for SID filings for Low-Acid Canned Food (LACF) submissions for pickles packaged in bottles. ( read more )
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        Medical Device manufacturer of non-invasive devices currently in clinical studies needs regulatory consulting for approval and marketing of the devices. ( read more )
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        California nutraceuticals company needs Regulatory Consulting for Import/ Export of dietary supplements to New Zealand and Latin America ( read more )
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        Pharmaceuticals company needs recent ex-FDA Medical reviewer, now consultant, from the Division of Antiviral Drugs who can assist in clinical/regulatory strategy. ( read more )
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        Medical Device Training Provider needed for Qualification and Validation Training in Dominican Republic. Course must be given in spanish language, in Santo Domingo, Dominican Republic, Date: March 15,16,17. ( read more )
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        Medical Device Manufacturer needs former FDA regulatory consultant for consulting on FDA 510(k). Consultant should have microbiology and Human factors engineering expertise for consulting on 510(k)which is currently filed with the FDA. Consultant would provide guidance in interacting with the FDA and going forward. ( read more )
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        Consultant needed to conduct marketing survey to assess potential in Brazil for finished pharmaceutical formulations from selected therapeutic categories. ( read more )
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        Cosmetics company needs a Quality Assurance Consultant for Quality Auditing of new subcontractor ( read more )
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        API manufacturer needs regulatory consultant to convert 2 European DMF's (in CTD format) for 2 of our API's (in English)into the required Japanese format for lodgement with our clients and the Japanese Department of Health. Must spaek Japanese or be located in Japan. ( read more )
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        US FDA medical device consultant needed for evaluation of FDA registration and approval filing requirements for in-vitro diagnostic whole blood testing kit for clotting time. The kit contains 3 different types of Class I devices, 1) Capillary tubes, 2) Finger cots, 3) Lancets (identital to the ones used by diabetics to draw capillary blood). There will be an instruction sheet showing customer as to how to use these devices to learn about his/her whole blood clotting time (no anticoagulant used). Please e-mail me since I am out of the country, and will be back in TX in March 1st week. Please let me know the hourly fees for your top notch medical device consultant as well. ( read more )
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        Pharmaceutical consultant or attorney needed for start-up OTC pharmaceutical manufacturer. Consulting includes registration, trademark, NDC and Bar Code Label applications, & other. ( read more )
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        FDA and ISO phramceuticals consultants to provide training on Validation and Qualification of computer systems in the pharmaceuticals industry with respect to FDA regulatory compliance. ( read more )
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        European Union food consultant need in Asia for EU registration of thermally processed low acid canned foods(LACF). ( read more )
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        Large chemical manufacturer seeking EPA/OECD or FDA Quality Assurance auditor located in Australia -- a self-employed individual or from a larger testing service company -- for occasional field audits in Australia during testing of household insecticides and/or personal repellents for USA company. ( read more )
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        Former FDA consultant needed to conduct mock FDA inspection for European IVD manufacturer (product includes reagents, instrument & software) in preparation for first FDA inspection. ( read more )
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        US company requires regulatory consultant knowledgeable of cosmetic labeling laws in India. ( read more )
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        Regulatory consultants needed for ANDA Application for generic pharmaceutical controlled release tablet formulations. ( read more )
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        Regulatory consultant needed to develop GLP Phase I studies for a USFDA Investigational New Drug IND Application for a nutraceutical. ( read more )
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        Pharmaceutical Consultant needed for Pharmaceuticals Good Manufacturing Practices (GMP) training for Pharmaceutical labeling and packaging company. ( read more )
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        Pharmaceutical Consultants needed for on-site validation of automated pharmaceutical process equipment for manufacturer of pharmaceutical equipment ( read more )
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        API manufacturer needs USFDA Regulatory Consultant well versed with FDA regulations for approval of Active Pharmaceutical Ingredient (API) facility by USFDA Authorities in India. It is a green field project. ( read more )
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        US medical device manufacturer needs regulatory medical device consultant for registering a medical device in Brazil. This product has been classified as a cosmetic, drug, Class I medical device, and Class IIa medical device in different countries. Experience with all classes in Brazil is highly desirable. ( read more )
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        Genomics company interested in finding consultants for setting up a high complexity CLIA lab for nucleic acid testing that meet the specific requirements of the state of california. ( read more )
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        "GLP inspectors, experienced in auditing toxicology facilities, analytical lab and bioanalytical lab. FDA experience preferred but not required." ( read more )
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        "Nutraceuticals firm would like FDA, GMP consulting for nutraceutical labeling" ( read more )
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        "FDA, GMP Contract Sterilizer needed to sterilize oil that will be used for implantation drug use and heart stents. This needs to be done without harming the oil's effectiveness. " ( read more )
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        "FDA consultancy for set-up of pre-IND meeting. Advice on development programme & identification of suitable clinical experts. Therapeutic area is short acting sedatives/anasthesia." ( read more )
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        UK based biotech / pharmaceuticals company that is looking to file and IND and NDA applications in the US. We need a consultant who would be prepared to act as our US agent?" ( read more )
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        US medical device executive is interested in the regulatory requirements for conducting an active implantable medical device clinical trial in India. ( read more )
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        "On-Line or Direct training on FDA ,EMEA ,MCA guidelines for the registration of pharmacuticals as well as herbal products" ( read more )
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        US FDA Medical Device Consultant needed for FDA approval for a low level laser ( read more )
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        Regulatory Consultant needed for Project Manager for Medical Device PMA application and study compliance" ( read more )
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        Experienced US FDA Medical Device Consulant needed for filing Medical Device 510(K) including collecting related information, pick SE predictive device, and are experieced in geting approval from FDA" ( read more )
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