Regulatory Strategy 

Our staff has significant experience across all application types (IND, NDA, BLA, ANDA, DMFs, and Orphan Drugs) from pre-IND preparation & strategy to annual reports. We have a comprehensive understanding of regulatory strategy and industry best practice.


We continuously monitor the regulatory environment and are apprised of changes in regulation or guidance documents and can advise your team accordingly. In addition to strategy work, we have an extensive skillset and can assist with regulatory document authoring.

We can attend regulatory meetings and/or conference calls representing your company in a Regulatory capacity. Our staff combined has over 70 years of experience.