Patheon's commercial supply 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 extensive documentation required when you bring a new product to the international marketplace. After hundreds of projects and filings we know exactly what it takes to eliminate any unnecessary delays.
Regulatory services for commercial supply at Patheon
- Supplemental New Drug Applications (sNDA)
- Biological License Applications (BLA)
- Marketing Authorization Application for the European Agency for the Evaluation of Medicinal Products (EMEA)
- Annual and informational updates and protocol amendments
- Type I/II Variations (EU)
- Drug Master Files (DMF)
- DMF/EDMF/CDMF preparation and maintenance
- CMC portions of IND and NDA/BLA (Modules 2 & 3 for quality and overall summary for the CTD)
- Certificate of suitability
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 represent you before regulatory agencies, and quickly address any questions they might have.
Patheon's regulatory services are a perfect example of the strength of our experience and fully integrated approach to development and commercial supply. It's part of what makes Patheon the fastest way to go from molecule to market.