Regulatory Strategy and Planning

Our partners offer strategic leadership and advice for the development of services such as agency meetings/interactions and preparations, strategic review of development plans, pre-approval inspections and preparation, change control assessments, Reference Listed Drug (RLD) and Inactive Ingredients Guide (IIG) excipient reviews, comparability studies, commercial control strategies, due diligence and gap analyses, risk assessments, controlled correspondence, and strategic advice on regulatory advocacy and policy.