International Regulatory Consultants for All your Regulatory Needs


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, etc? Learn More

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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, etc. Learn More

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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, etc? Learn More

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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, the pharmaceuticals, biopharmaceuticasl, biotechnology, medical devices, in-vitro diagnostics, biologics, animal drug, clinical trial, nutraceuticals, dietary supplement, chemical, cosmetics and food and beverage industries. Learn More

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