Approval and Post Approval
A reputation for high-quality built one project at a time.
From 2006 through 2015, Patheon, a part of Thermo Fisher Scientific, helped clients earn 92 new drug application (NDA) approvals. That’s twice as many as any other CMO/CDMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.
Depth of expertise and resources. Responsiveness and flexibility. Dependable quality. Parallel active pharmaceutical ingredient (API) and finished dose development. Right First Time/On-time reliability. Work with a team that understands the approval process inside and out. Seasoned experts who know exactly what’s required and the pitfalls that lead to costly delays. Our team’s ability to consistently deliver high quality in everything we do has earned us the trust of the world’s top 20 pharmaceutical companies, and 18 of the top 20 biotech companies.
Where some may view regulatory inspections as a hurdle, we view them as an impartial measure of excellence. In the past 10 years, our facilities have undergone more than 325 regulatory inspections and 33 PAIs waived by the U.S. FDA. Patheon, a part of Thermo Fisher Scientific, has consistently delivered this level of quality for clients year after year, for more than 10 years.
Last year alone, we manufactured more than 700 large and small molecule products approved for more than 70 countries. But success isn’t just scale, it is also our ability to deliver exceptional quality and service. In 2008, 2010, 2011 and 2012 we were recognized with The European Outsourcing Award for Most Effective Scale-up and Technology Transfer.
Source: PharmSource® Trend Report, March, 2016.