各国の規制当局の承認を得るために薬事申請書類を作成するには、多大な専門知識と労力、そして細部への配慮が求められます。承認申請の成功には、多様な分野の専門家で構成された大規模なチーム、多数のツール、計画策定、各々のプロセス、その全てが互いに連動することが不可欠です。複雑性、リスク、時間、コストがすべての提出物に伴います。慎重に実行し予想外の課題を乗り越える能力がなければ、提出物はコストを伴う遅延に見舞われる可能性があります。

Certara assures and accelerates the approval of, and access to, medical innovations through a unique combination of customized regulatory strategy, document authoring, medical affairs and scientific communications, and operations solutions. Our proven record of success is built on our expertise and an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.

What our partners have to say:

“I consider [Certara] to be the gold standard for our vendors because of the excellent service they provide.” – Vice President, Regulatory Affairs | Banner Life Sciences社

“You may have seen the announcement that the FDA has accepted our NDA filing. I just want to say, thank you to each and everyone else at Certara who helped us get to this point. There’s more to come, but this is a big deal for us and soon for patients. We couldn’t have done it without you.” – Vice President, Program Management at a biopharmaceutical company