BLA Prep Offerings

 Regulatory Submissions

Regulatory submissions are complex and critical to a drug development program; content requirements for CTD format are not always clear. Responding to agency questions requires care in ensuring that the response fully addresses the request for additional information. Knowing what to include, how to include it and where and when to include it – as well as knowing what to leave out – takes years of experience. CMC Compliance Services has that experience.

Regulatory agency reviewers are very busy people. The easier it is to review a document, the less time it takes to review it. CMC Compliance Services prepares regulatory submissions in reviewer-friendly language, with clear tables and graphics that provide snapshots of the critical data. 

Agency Interactions

Understanding what the agency expects in a meeting can make the difference between a successful meeting and an exercise in frustration. The importance of being prepared cannot be underestimated. CMC Compliance Services has the experience to help clients prepare and conduct meetings that meet agency expectations, including pre-meeting briefing packages, slide preparation, meeting rehearsals, information presentation, and minutes preparation.