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Pharmaceuticals, Medical Device, Biologics, Healthcare, Clinical Trials,
Dietary Supplements, Food and Beverage, and Cosmetics Industries.

Global Regulatory Consulting Services


FDA Regulatory Submissions

Need ex-FDA consultants or FDA 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

FDA Compliance

Need FDA 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

FDA Audits or Mock Inspections

Need ex-FDA consultants for conducting FDA cGMP audits, Pre-Approval Inspections or Mock Inspections 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

FDA cGMP and Quality Systems Training and Eduction
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

FDA Recalls and Crisis Management

Did your FDA regulated 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

FDA Labeling and Promotional Materials Consulting

Need attorneys or regulatory consultants for development and evaluation of labeling and promotional materials for the regulatedPharmaceuticals, 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

cientific 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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