Value through Innovation17 January 2013
Excellent regulatory track record and quality for your success
Boehringer Ingelheim has a long and highly successful track record in inspections of all its pharmaceutical production sites around the globe, giving customers and partners optimal assurance of quality and efficiency. Our inspection history is excellent in the USA, Europe, and Japan as well as in Asian and Anvisa markets.
We offer
- Regulatory expertise and support – from consulting to complete dossier and Drug Master File (DMF) preparation.
- State-of-the-art Good Manufacturing Practice (c-GMP) compliance
- Full analytical development and validation services
- Experienced launch team
Drug Product Sites
Drug Substance Sites
Our Excellent regulatory track record
We have a long and highly successful track record in inspections of all our sites:
- US Food and Drug Administration (FDA)
- US Drug Enforcement Administration (DEA)
- EU (EMEA/MHRA)
- PMDA (Japan)
- ANVISA (Brazil)
- ANMAT (Argentina)
- ANVIMA (Colombia)
- Gulf Cooperation Council
- TGA (Australia)
- NDA (Uganda)KFDA (Korea)
- BFDA (Taiwan)
