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