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Global Regulatory
The International Regulatory Outsourcing Network.
18 June 2013

Account Management

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Regulatory Consulting Requests for Proposals
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Find Audit regulatory consultants for all your Audit consulting, audits and training such as regulatory submissions, regulatory compliance, advisory meetings, validation, regulatory actions, warning letters, import detentions, exporting, importing, seizures, non-approvals, FDA, Good Manufacturing Practices in countries such as the USA, Canada, Mexico, European Union, United Kingdom, Ireland, China, Japan, Australia, etc.

Audit Requests for Proposals

Global Regulatory.com has received the following incoming Audit Requests which need to be fulfilled ! These Audit Requests are received from a variety of sources ranging from start-up companies to large, multinational corporations actively seeking companies to perform their Audit services. If your company receives requests that it can not fulfill, please refer them to us! If you have questions, please e-mail us or call 403-770-1994 .
Incoming Audit Requests
#
Audit request description
status
13-0013 Manufacturer needs ISO consultant / FDA GMP consultant or auditor to come verify their laboratory testing for USP material" ( read more ).....
13-0007 Maryland laboratory auditor needed to perform a GLP / CLIA audit prior to launching the program. ( read more ).....
13-0005 Regulatory Consultant needed for FDA Quality Audit, Quality system to compliance with FDA Regulations ( read more ).....
Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued. ( read more ).....
Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits ( read more ).....
USA ex-FDA consultant needed for 510k and GMP audit ( read more ).....
FDA NDA Submission, EU CTD, FDA GMP Vendor Audit, ISO Compliance, Expert Witness, Validation & Qualification, Import/Export, Registered Agent, Labeling and Advertising Reviews, Quality Systems, SOP Wr ( read more ).....
This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility t ( read more ).....
12-000059 International agency needed to audit a laboratory with GLP principles and issues a certificate ( read more ).....
12-000053 FDA Consultant needed for FDA GMP vendor audit in India ( read more ).....
12-000035 Unmanned aerial vehicles and radar solutions company for military and commercial applications seeking onsite training of Federal, California, Los Angeles County, and San Bernardino County environmenta ( read more ).....
12-000024 Clinical Trial Regulatory Consultant needed for Turkey MoH audit of site for clinical and bioequivalence studies ( read more )..... Closed
12-000012 In need of an auditor trainer as part of annual refresher training. ( read more ).....
12-000007 US FDA Consultant needed for FDA Audit training and preparation guidance ( read more )..... Closed
11-000122 Biologic Manufacturer needs ex FDA CDRH inspector to conduct a mock 21CFR820 audit at our manufacturing facility. ( read more )..... Closed
11-000081 FDA Consultant needed for Gap analysis of cGMP. Currently in Phase II clinical trial. Request proposal to audit production facility and provide recommendations to meet compliance requirements necesa ( read more )..... Closed
11-000061 This is a cost estimate only: We need a highly qualified auditor to provide costing to accomplish the following: Perform a Center-Initiated Regulatory Compliance Audit (specifically with respect t ( read more )..... Closed
11-000034 Expert in the state laws governing the issuance of personal automobile insurance policies. This individual must have experience building a comprehensive compliance and supporting audit plan in regard ( read more )..... Closed
11-000031 China independent consultant needed with a deep understanding of the SFDA (& FDA) regulatory environment and requirements;local experience in regulatory applications for clinical trials and registrati ( read more )..... Closed
11-00023 San Diego Biotechnology company needs a virology expert who also has quality assurance background to conduct an audit of a medical laboratory that is in the Netherlands. Would Global Regulatory be ( read more )..... Closed
10-00150 India and China Regulatory Consultant needed toevaluate and identify requirements for the dossier assembly and submission of license applications for an existing US OTC to be marketed in India and Chi ( read more )..... Closed
10-00146 FDA Quality Systems Consultant needed for FDA GMP, SOP writing, manual set-up for vendor audit ( read more )..... Closed
10-00125 Medical Device Manufacturer needs GMP Consultant for GMP Vendor Audit ( read more )..... Closed
10-00124 Health Canada Regulatory Consultant needed ASAP to conduct OTC drug GMP audit to Canadian Drug GMPs is required for an over the counter drug product manufacturer in India. This audit needs to be cond ( read more )..... Closed
10-00121 Regulatory Company needed for FDA ANDA Submission, EU CTD, FDA GMP Vendor Audit, ISO Compliance, Validation & Qualification, Import/Export, Labeling and Advertising Reviews, Quality Systems, SOP Writi ( read more )..... Closed
10-00093 India company needs Quality Consultant for Quality Assurance Training needed for the quality auditing, in brief with respect to QA and regulatory ( read more )..... Closed
10-00068 NY Medical Device Manufacturer seeks long term regulatory and quality management consultant, Maintenece of FDA, CE, ISO compliance, update of technical file, Internal quality audits. minimum 2 days at ( read more )..... Closed
10-00052 FDA GMP Regulatory Consultant needed for GMP compliance audit ( read more )..... Closed
10-00043 Medical Device Consultant needed for FDA Internal audit assistance ( read more )..... Closed
10-00040 Government needs regulatory auditor to assist on good inspection practice of pharmaceutical warehouses (importers and wholesalers), post market surveillance ( read more )..... Closed
10-00020 USA ISO, GLP, GCP, ASQ certified auditor needed for pre-clinical and clinical bioanalytical laboratory (Method validation, Sample Analysis)and quality systems that support these activities." ( read more )..... Closed
09-0159 Regulatory Consultant with US and China regulatory consultants needed for FDA GMP audits and monitor compliance of a pharmaceutical plant in China. We have a project to buy a pharmaceutical API from C ( read more )..... Closed
09-0121 Need: A two-day audit (1 auditor needed for both days). Combination of Team Biologics style and QSIT Medical Device style audit. Focus on CAPA systems, Complaints and DAE, Document Control, Training, ( read more )..... Closed
09-0096 Laboratory Consultant required to conduct a lab audit to verify the proper mechanisms and procedures are in place (SOPs, training verification, change control, etc). My organization contracts with a l ( read more )..... Closed
09-0085 Clinical Trial Auditor needed for auditing a Pharmaceutical Clinical Trial ( read more )..... Closed
09-0080 Pharmaceutical Mfg needs qualified ANVISA consultant to audit CRO for BE/BA studies for ANVISA (Brazil) ( read more )..... Closed
09-0048 Chemical Manufacturer of plastic color concentrates needs Regulatory Consultant to conduct Regulatory Audit. ( read more )..... Closed
09-0030 Chemical Supplier looking to expand into food applications needs FDA Food Consultant to audit two facilities for FDA GMP inspection and then develop a GMP operating protocol that meets 21 CFR 110 req ( read more )..... Closed
09-0018 Toy manufacturer needs Product Safety Consultant for factory audits, inspectins and writing product safety procedures and protocol for consumer products/toy company. Also included would be procedures ( read more )..... Closed
08-0174 Pharmaceutical Manufacturer exploring the possibility of a FDA GMP audit of an API manufacturing facility in Germany. Auditor must speak, read and write German and English. ( read more )..... Closed
08-0164 Qualified GCP auditor needed to audit a Phase 3 clinical studies ( read more )..... Closed
08-0150 Consultants or training courses needed for lead auditors training against FDA regulations specificially 21 CFR part 820 ( read more )..... Closed
08-0139 Regulatory Auditor needed to conduct mock FDA style audit and gap analysis of contract laboratory in India that is conducting clinical testing for health care personnel hand wash products. ( read more )..... Closed
08-0133 Regulatory consultant needed for veterinary FDA Good Clinical Practices audit ( read more )..... Closed
08-0113 NY Metropolitan Area Medical Device Regulatory Consultant needed for FDA Quality Assurance / Regulatory Affairs assistance including: Batch record & review, electronic records, Quarterly quality syste ( read more )..... Closed
08-0112 Canada Medical Device Manufacturer needs FDA Consultant to do FDA mock audit done to prepare for possible FDA audit. Our products are medical devices such as flowmeters, gas regulators, hoses, vacuum ( read more )..... Closed
08-0087 Regulatory Consultant needed for Nutritional Supplement industry compliance and famility audit. Heavy in QC lab testing, methods development, GLP. Also looking for facility audit. ( read more )..... Closed
08-0046 Regulatory consultant needed to assist on Country of origin certificate, Countinuing letter of guaranty and the latest third party audit for the manufacturing plant for all the spices. ( read more )..... Closed
08-0024 Audit of two central labs in Argentina (Buenos Aires) and two central labs in India (Ahmedabad and Bangalore). ( read more )..... Closed
07-0145 Regulatory consultant needed for providing points of view on audit ( read more )..... Closed
07-0126 Quality Consultant needed for conducting a Quality System Audit of a factory in Beijing, China, to ensure compliance with FDA QSR for medical device manufacturing. ( read more )..... Closed
07-0114 USFDA Regulatory Consultant needed for consulting on USFDA audit ( read more )..... Closed
07-0085 Contract Manufacturer of pharmaceutical packaging needs FDA regulatory consultant to audit processes for FDA Good Manufacturing Practices GMP. ( read more )..... Closed
07-0078 FDA consultant needed for FDA GMP audit of dietary supplements manufacturing plant for FDA GMP compliance. ( read more )..... Closed
07-0065 Clinical Quality consultant needed to provide GCP Audit Training in QA Good Clinical Practices Auditing on study site for pharmaceutical CRO ( read more )..... Closed
07-0046 Assistance in preparation of USFDA DMF submission for pharmaceutical raw material, GMP assistance and audit preparation for USFDA audit. ( read more )..... Closed
07-0032 Medical Device Regulatory Consultant needed for GMP Audits for medical devices ( read more )..... Closed
07-0031 Chemical Manufacturer seeking EPA/OECD Quality Assurance auditor located in Australia -- a self-employed individual or from a larger testing service company -- for occasional field audits during testi ( read more )..... Closed
06-0162 Consultant needed to conduct audits of clinical trial centres, TMF's ,related systems etc. to ICH GCP standards ( read more )..... Closed
06-0146 Large chemical manufacturer needs Quality Assurance QAU auditor for field efficacy studies of household insecticide products and personal or area repellents ( read more )..... Closed
06-0145 Auditor need to perform a Food Plant Audit for a client. ( read more )..... Closed
06-0141 Consultants needed for assisting on the training and obtaining licenses for Biomedical Research auditing and Quality Assurance. ( read more )..... Closed
06-0135 Pharmaceuticals manufacturer needs consultant for consulting on Canadian regulatory requirements i.e Audit requirements, dossier requirements and others ( read more )..... Closed
06-0094 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 )..... Closed
06-0078 Pharmaceutical manufacturer needs pharmaceutical regulatory consultant to guide them in US FDA audit and regulatory documentation matters. ( read more )..... Closed
06-0071 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 pharmaceutic ( read more )..... Closed
06-0069 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. Afforda ( read more )..... Closed
06-0055 Clinical Pharmaceuticals Regulatory Consultant needed for clinical research training in the area of quality assurance / auditing techniques / auditor. ( read more )..... Closed
06-0027 Cosmetics company needs a Quality Assurance Consultant for Quality Auditing of new subcontractor ( read more )..... Closed
06-0021 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 ( read more )..... Closed
06-0011 "GLP inspectors, experienced in auditing toxicology facilities, analytical lab and bioanalytical lab. FDA experience preferred but not required." ( read more )..... Closed
05-0065 "FDA GMP consultant needed for advising on proper building construction and manufacturing requirements for GMP audits and certification." ( read more )..... Closed
05-0052 Medical Device Auditors needed for FDA mock inspection to assess compliance to the Quality System Regulation, including 21 CFR part 11 (were applicable). Mid-January 2006 ( read more )..... Closed
05-0051 ""on-site 3-5 day training session for clinical trials/monitoring for auditors. 10-15 persons for the first week of December 2005"" ( read more )..... Closed
05-0029 Certified body needed for US FDA GMP audits of manufacturers of Supplementary and Nutritional products (Nutraceuticals) in California and issue GMP compliance certificates for respective production f ( read more )..... Closed
05-0024 Regulatory consultant needed for consulting on registering an arnica montana based ointment, which is registered in mexico as an homeopathic treatment. We want to introduce this product to USA, in th ( read more )..... Closed
05-0016 Quality consultant needed for auditing quality system for combination product (a drug eluting stent) compliance" ( read more )..... Closed
05-0005 USA FDA GMP consultant neeeded for Pharmaceutical GMP Vendor Audit Checklist. Budget $99 " ( read more )..... Closed
05-0003 FDA GMP regulatory consultants to audit pharmaceutical manufacturing facility for cGMP compliance and other related services for pharmaceutical manufacturer." ( read more )..... Closed

For more information on Audit services, please call 1-403-770-1994 or email us

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