Regulatory Publishing Expertise Across The Entire Development Journey

Efficiently handling the publication of documents necessary for a regulatory registration submission can expedite the process of bringing your product to the market. In a recent case, one sponsor needed to file a high-quality IND submission and its CSR publishing to the FDA. However, the team was relying on an understaffed regulatory affairs team for the job.

In another separate case study, a sponsor was looking to submit an MAA submission to the EMA but was struggling with quality issues and delays. And in a third case, one commercial-stage sponsor sought help with their NDA submissions, amendments to documents, and ad promo submissions.

Learn how with expert support, all three sponsors were able to issue flawless IND, MAA, and NDA submissions to the FDA and EMA.