NDA Approval And Post Approval Services

Source: Patheon – part of Thermo Fisher Scientific


From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. 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.

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Depth of expertise and resources. Responsiveness and flexibility. Dependable quality. Parallel 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 Patheon the trust of the world’s top 20 pharmaceutical companies, and 8 of the top 10 biotech companies.

Where some may view regulatory inspections as a hurdle, Patheon views them as an impartial measure of excellence. Since 2004, our facilities have undergone more than 230 regulatory inspections, with nearly 20% resulting in zero observations and 30 PAIs waived by the U.S. FDA. Patheon has consistently delivered this level of quality for clients year after year, for more than 10 years.

Last year alone, we manufactured more than 800 large and small molecule products across 2,100+ SKUs 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.

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Patheon – part of Thermo Fisher Scientific