Regulatory Dossier Support Services

The key to a delay-free submission is completeness and accuracy. Patheon's regulatory dossier support is a perfect example of the strength of our experience and fully integrated approach to late development. 

Patheon's late 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.

Late development regulatory dossier support at Patheon

• New Drug Application (NDA) for U.S.
• MAA for EU
• 505 (j) - ANDA
• 505 (b)(1)
• 505 (b)(2)

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 dossier support is a perfect example of the strength of our experience and fully integrated approach to late development. It's part of what makes Patheon the fastest way to go from molecule to market.