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| Regulatory Consulting |
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The Regulatory Network.
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| Serving such industries as Pharmaceuticals, Biotechnology, Medical Devices & In-Vitro Diagnostics, Healthcare, Food & Beverage, Clinical Trials, Nutraceuticals, Cosmetics, Animal Health, Consumer Products, etc |
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Most Recent Incoming Regulatory Consulting Requests |
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Regulatory Consulting
Description |
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Labeling and Advertising |
Regulatory consultant needed for labeling consulting for shampoo manufacturer that is rebranding a hair care line including shampoos, conditioners, styling products into our own brand name. We will be selling these products in Australia, USA, Canada, Africa. Later in to other con tries.
We needs gu(
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Registrations, Submissions, Licenses and Filings |
US FDA Consultant needed for FDA ANDA submission services. We are in the feasibility stage and would like to discuss.
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Training and Education |
US FDA Consultant needed for FDA Audit training and preparation guidance(
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Registrations, Submissions, Licenses and Filings |
Regulatory Consultant needed for registration of biosimilars and search for local agent in the required countries(
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Registrations, Submissions, Licenses and Filings |
Consumer Products consultant needed to advise on consumer products regulatory requirements in different countries in the world. (
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| 10 Most Recent Registered Regulatory Consultants |
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| 5 Most Recent Legal and Regulatory Job Openings |
![KEY RESPONSIBILITY:
Serve as a scientist for assigned preclinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
With minimal guidance, serve as a as a study director]() Study Director General Toxicology
Suzhou Xishan Zhongke Drug Research & Development Co., Ltd. -.KEY RESPONSIBILITY:
Serve as a scientist for assigned preclinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.
ESSENTIAL DUTIES AND R.. |
 Senior Program Officer, Quality Assurance and Regulatory, Vaccine Development
Sabin Vaccine Institute -.The position is primarily focused in preclinical vaccine development activities, including oversight/improvement of new/existing documentation systems/databases. Candidate will help in defining programmatic milestones and assessing critical resources/timelines. Duties incl.. |
![Plan, direct and coordinate the operational activities of the microbiology and analytical labs.
Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Ensure quality systems are being applied in the performance and documentation of lab studies and production]() Laboratory Manager
Unicep Packaging, Inc. -.Plan, direct and coordinate the operational activities of the microbiology and analytical labs.
Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Ensure quality systems are being .. |
 Research Officer
Intertek -. Method development and validation in various chromatography techniques.
Method development and validation for active ingredient, stability, homogeneity analysis.
Method development and validation for residue and persistence study.
Field trial and laboratory study.. |
 ANIMAL CARE (RESEARCH SUPPORT) SUPERVISOR
SNBL USA -. * Maintain Good Laboratory Practices (GLP)
* Monitor and assure that all regulatory and/or applicable documentation is appropriately recorded, filed and accessible for inspections, reports, etc.
* Ensure direct reports' compliance with departmental standard op.. |
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| 5 Most Recent Legal and Regulatory Training Courses and Conferences |
 The new Variations Regulation - Strategies for Grouping and Worksharing
Michor Consulting e.U - Pharmaceutical products change over time; the drivers of changeinclude innovation, continual improvement, the output of process performanceand product quality monitoring and CAPA among others (ICH-Q10 -PharmaceuticalQuality System). In most territoriespost approval changes must be recorded and notified to the competent authorities. In the EU Regu... |
Quality by Design (QbD) and Post-approval change management protocols
Michor Consulting e.U - Quality by Design (QbD) is a concept that affects regulatory documentation andinformation provided by manufacturers to the authorities. Recent developments in QbD have had apositive impact on life cycle management and the management of post marketinformation. QbD can help to avoidquality issues by proper planning in the development stage leading ... |
![The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalCompliancePanel]() The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalCompliancePanel
Global Compliance Panel - Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appr... |
![Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel]() Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel
Global Compliance Panel - Overview: This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications.
Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vend... |
![Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel]() Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel
GlobalCompliance Panel - This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future.
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to... |
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| Regulatory Requests Areas |
International Regulatory Submissions
Need regulatory consultants or attorneys for filing, preparing, or compiling regulatory submissions, applications, registrations, amendments, accreditations, amendments, approvals, licensures, and certifications specializing in pharmaceuticals, medical devices, food and beverages, biotechnology, nutraceuticals and cosmetics industries. Need regulatory consultants or attorneys for filing submissions such as US FDA Pharmaceutical New Drug Applications (NDA) , EU Common Technical Documents (CTD), FDA Biologics License Application (BLA),CE Marking, IND/CTEX, NDA/MAA, Investigational New Drug IND, Abbreviated New Drug Applications ANDA, Pre-Market Approvals, PMA, 510ks, Drug Master Files, DMF, Technical Files, Declaration of Conformity, DIN submissions, CE Marking, CLIA Waivers, etc.Find regulatory consultants and lawyers for all your Regulatory Submissions needs! Submit Regulatory Requests for Submission Services |
Regulatory Compliance
Need regulatory consultants or attorneys for regulatory compliance services such as evaluation of the compliance of pharmaceuticals, biopharmaceuticals, clinical trials, in-vitro diagnostics, combination products, medical devices, consumer products, animal drugs, cosmetics, nutraceuticals, food and beverages to international government regulations, laws, guidelines, and industry standards such as US FDA FD&C, Good Manufacturing Practices, GMP, Good Laboratory Practices GLP, Good Clinical Practices GCP, HAACP, Part 11, European Directives, Medical Device Directive MDD, EU EHS, In-Vitro Diagnostic Directive IVDD, CEN Standards, CE Marking, ICH Standards, ISO 9002, Health Canada, Japan Ministry of Health, Australia Therapeutic Goods Administration TGA , etc? Find regulatory consultants and attorneys for all your regulatory compliance needs! Submit Regulatory Requests for Compliance Services |
International Regulatory Auditing
Need regulatory consultants or auditors for conducting due diligence, internal audits, or supplier vendor audits such as Global Harmonization Task Force GHTF SG 4 Regulatory Audits, Good Manufacturing Practices GMP Audits, Good Laboratory Practices GLP Audits, Good clinical Practices Audits, Mock Food and Drug Administration Inspections, ISO Audits, Pharmaceutical Inspection Convention (PIC) Audits, Quality Audits, Vendor Qualification Audits, Software Quality Audits, Sarbanes-Oaxley Audits, HAACP Audits, etc.in the pharmaceuticals, biopharmaceuticasl, biotechnology, medical devices, in-vitro diagnostics, biologics, animal drug, clinical trial, nutraceuticals, dietary supplement, chemical, cosmetics and food and beverage industries. Find regulatory consultants and auditors for conducitng all your regulatory supplier vendor audits, internal audits and due diligence needs! Submit Regulatory Requests for Audit Services |
International Quality and Regulatory Training
Need regulatory consultants for in-house, off-site, or on-line regulatory and quality training programs, courses, webinars, conferences, or seminars such as Good Manufacturing Practices GMP training, Good Laboratory Practices GLP Training, Good Clinical Practices GCP training, ISO training, Common Technical Documents Training, Post Market Surveillance Training, CE Marking Training, EU Medical Device Directives MDDD Training, EU Clinical Trials Directive Training, Part 11 Training, Process Validation Training, Vendor Audit Training, Clinical Research Monitoring Training, Quality Systems Training, Pharmaceutical Development Training, EudraVigilance Training, HAACP training within the Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Trials, Food and Beverages, Veterinary Medicine, Nutraceuticals and Cosmetics Industries? Find regulatory consultants and trainers for all your regulatory and quality training! Submit Regulatory Requests for Training Services |
Quality Services Consulting
Need quality consultants for Quality Systems consulting such as FDA, Good Manufacturing Practices GMP, QSR, ISO, quality systems, quality assurance and quality control (QA & QC) quality plans, quality manuals, and quality standard operating procedures, master batch records, device master files, corrective and preventative action (CAPA) systems for the pharmaceutical, biopharmaceutical, combination products, clinical trial, healthcare, medical device, in-vitro diagnostic, biotechnology, animal drug, cosmetic, chemical, consumer product, dietary supplement and food and beverage industries? Find Quality consultants for all your quality systems consulting services! Submit Regulatory Requests for Quality Services |
Government Liasion
Need attorneys or regulatory consultants for government relation services such as liasion services, US Designated Agents, European Authorized Representative EAR, FDA inspection facilitation and remediation, FDA responses, FDA warning letters, FDA seizures, FDA recalls, FDA advisory meetings, etc. for the pharmaceuticals, biopharmaceuticals, combination products, clinical trials, healthcare, medical devices, in-vitro diagnostics, biotechnology, cosmetics, veterinary medicine, chemical, consumer products, dietary supplements and food & beverage industries? Find lawyers and regulatory consultants for all your government relations consulting! Submit Regulatory Requests for Government Liasion Services |
Recalls and Crisis Management
Did your manufacturing company have a product failure and needs to recall product? Has a regulatory body like the US FDA just issued a warning letter or maybe seizing your product? Need attorneys or regulatory consultants for Crisis and Risk Mananagement consulting such as recalls, medical device reports, safety alerts, product failures, vigilance, post market surveillance, crisis intervention, pharmacovigilance, public relations of pharmaceuticals, biopharmaceuticals, combination products, medical devices, in-vitro diagnostics, biologics, animal drugs, cosmetics, consumer products, food and nutraceutical recalls and safety alerts. Find lawyers and regulatory consultants for all your crisis management and risk management needs! Submit Regulatory Requests for Crisis Management Services |
Exportation and Importation Consulting
Need regulatory consultants, US designatd agents, attorneys or customs brokers for customs consulting, importation, exportation or shipping of materials, parts, equipment or finished regulated products such as Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Supplies, Food and Beverages, Animal Drugs, Consumer Products, Nutraceuticals, Manufacturing Equipment, Scientific Instruments, and Cosmetics within countries such as USA, Canada, Ireland, China, Japan, Australia, Mexico, Argentina, Brazil, France, Germany, Russia, Italy, United Kingdom, etc? Find regulatory consultants, US designated agents, attorneys, or custom brokers for all your exportation and importation needs! Submit Regulatory Requests for Export and Import Services |
Labeling and Promotional Materials Consulting
Need attorneys or regulatory consultants for development and evaluation of labeling and promotional materials for the regulated Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Supplies, Food and Beverages, Animal Drugs, Consumer Products, Nutraceuticals, and Cosmetics? Find independent regulatory consultants, regulatory consulting firms or lawyers for all your labeling and promotional materials needs! Submit Regulatory Requests for Labeling Services |
Scientific and Technical Consulting
Need scientists, engineers, and technical consultants for specific technical or scientific projects with computers, software devleopment, toxicology, cytology, industrial hygiene, microbiology, pharmacokinetics, molecular biology, statistics, bioengineering, pharmacogenomics, genetics engineering, animal science, physiology, histology, protein chemistry, virology, food chemistry, nutrition, immunology, etc.? Find scientists, engineers and technical consultants for all your scientific and technical consulting needs! <Submit Regulatory Requests for Scientific and Technical Services |
Qualification and Validation
Need quality consultants, technical consultants, regulatory consultants or engineers for project management, review, and implementation of Qualification and Validation Programs such as Equipment Validation ( IQ, OQ, PQ), Cleaning Validation, Methods Validation, Process Validation, Medical Device Design Validation, and Computer Validation (Part 11) or to ensuree validation compliance to EU Directive 98/79/EEC and 21 CFR 820 in the pharmaceuticals, in-vitro diagnostics, biopharmaceuticals, medical devices, combination products, in-vitro diagnostics, and veterinary medicine processing, shipping, testing, packaging, sterilization, and manufacturing such as fermentation, tabletting, lyophilization, bioprocessing, etc.? Find technical consultants, quality consultants, quality engineers, regulatory consultants or engineers for all your qualification and validation projects! Submit Regulatory Requests for Validation Services |
Regulatory Consulting
Need regulatory consultants or attorneys for regulatory consulting services such as US FDA Pharmaceutical New Drug Applications (NDA) , EU Common Technical Documents or FDA Biologics License Application BLA regulatory strategy development, regulatory submissions, approvals, certifications, and licenses, post market surveillance, regulatory compliance, labeling reviews, expert witnesses, regulatory audits, remediation, interim regulatory affairs management for the pharmaceuticals, biopharmaceuticals, combination products, medical devices, in-vitro diagnostics, biotechnology, food and beverages, healthcare, nutraceutical, veterinary medicine, chemical, consumer products, and cosmetics industries. Find Regulatory Consultants and Attorneys in areas such as USA, Canada, European Union, South America, India, Ireland, United Kingdom, Japan, Asia, Australia, China, etc. Submit Regulatory Requests for Consulting Services |
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International Regulatory News
UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ...
Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled.
The Trident Catheter Valve is used for connecting a urinary cath...
TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods
media release, The Hon Catherine King MP
8 December 2011
The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert...
Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel...
Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel...
UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
2011-11-11 00:00:00
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher...
ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
2011-11-08 00:00:00
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving...
Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
2011-11-01 00:00:00
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ...
FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
2011-10-26 00:00:00
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).
The centers, which will be located at the University of Maryland and Georgeto...
2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl...
FDA approves Onfi to treat severe type of seizures
2011-10-26 00:00:00
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t...
Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
2011-10-19 00:00:00
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr...
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