Our regulatory philosophy
At Boehringer Ingelheim Pharma Chemicals we support our customers with all the necessary services regarding regulatory and other required documentation.
Extensive service
To ease the regulatory process, we provide all relevant regulatory documents. The respective drug master files and certificates of suitability (CEP) for our products are developed in-house. As commonly practiced, we submit these documents to authorities and to our customers after the conclusion of a secrecy agreement, where appropriate.
Special diligence
Strict adherence to the documentation requirements of the regulatory authorities is a matter of course for us. This applies equally to the final documents that are actually submitted, as well as to batch records and other operational documentation.
A higher level of involvement
At Boehringer Ingelheim however, our efforts go far beyond the letter of the law. We seek dialogue with regulatory authorities and demonstrate that we are in a partnership with those responsible for protecting the health and wellbeing of the world's population.
Quality regulation links
- Current Good Manufacturing Practices (cGMP)
- Deutsches Institut für Normung - DIN (German Institute for Standardization)
- Environment, Health and Safety Online (EHS)
- Food and Drug Administration (FDA)
Highest quality from start to finish
Learn more about our quality standards.
