Worldwide Expertise in Registration
Boehringer Ingelheim maintains a broad product portfolio with regulatory expertise in all regions. A combination of decentralised offices and strong guidance by our regulatory centre at Headquarters ensures consistent registration success on a worldwide basis.
Approvals in more than 120 countries
We profile our products for worldwide registration and perform marketing and sales in Europe, the Americas, Japan, Asia, Australia, New Zealand and Africa. We maintain approvals in more than 120 countries. Our regulatory people are partners to our project teams in the development of in-licensed projects and continue to support the product once it is successfully registered.
Broad experience has been gained in successful interactions with regulators and development teams from other companies regarding joint developments and registrations with split responsibilities.
Specific know-how in registration of biopharmaceuticals
For approval of biopharmaceuticals we made numerous filings for 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. For our industrial customers we support regulatory documentation for the CMC section.
Highly sophisticated electronic tools are used to process applications and all required documentation regarding compilation and publishing. Our regional centres help to adapt these international dossiers to local standards, if required.
