Partner & Links

EU

EudraLex – Vol4 (GMP) Guidelines
EU GMP Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use.

European Medicine Agency – Scientific Guidlines
Scientific guidelines of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to help applicants prepare marketing-authorisation applications for human medicines.

US

U.S. Food and Drug Administration

FDA – search database of Code of Federal Regulations Title 21
CFR – Code of Federal Regulations Title 21. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

FDA – Guidance (Drugs)
Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

Search database Warning letters
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Partner

Bernd Renger Consulting
Bernd Renger Consulting activities include services and support for clients working in the GXP regulated pharmaceutical industry, including biopharmaceutical and OTC, sterile or aseptic manufacturing and API production.

M bioserviceS
M bioserviceS help users of biological products get access to new sources or markets and get regulatory, quality and logistics support as required.

IT & Web Services

Acor EDV Consulting Lang
Offers hardware, software, consulting, internet and telephone services.

 

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