Regulatory Support

Expertise in biopharmaceutical registration

We have gathered valuable experience with the registration of biopharmaceuticals, having filed numerous applications with Investigational New Drug (IND), Clinical Trial Exemption (CTX), Biologics License Application (BLA) and New Drug Application (NDA) for therapeutic proteins, monoclonal antibodies, soluble receptors and gene therapeutics over the years. With this expertise we support our customers in preparing the regulatory documentation for the CMC section.

We have developed highly sophisticated electronic tools with which to process applications and compile the required documentation for publishing. Our regional centers will be glad to help you adapt these international dossiers to meet local standards if required.

Contact Us

Boehringer Ingelheim BioXcellence - Contact Us

Do you have any inquiries, questions or comments? Please get in touch with us.