Patheon's early development customers can benefit from our years of experience working with regulatory agencies in the U.S. and around the world. We can provide you with extensive documentation prepared in the format required for the Chemistry, Manufacturing & Controls (CMC) section of your regulatory submissions. After hundreds of projects and filings we know exactly what it takes to eliminate any unnecessary delays.
Early development IND/IMPD dossier support at Patheon
- Investigational New Drug (IND) for the US
- Investigational Medical Product Dossier (IMPD) for EU
The key to a delay-free submission is completeness and accuracy. As the source of the data, Patheon will be more familiar with it than any third party vendor. And because of our seamless integration, the flow of that data will be fast and efficient. What's more, we will assist you in discussions with regulatory agencies, and quickly address any questions they might have.
Patheon's IND/IMPD dossier support is a perfect example of the strength of our experience and fully integrated approach to early development. It's part of what makes Patheon the fastest way to go from molecule to market.