Strategy & Planning

• Development of regulatory strategies
• Assessment of existing regulatory strategies and timelines and provide recommendations for change
• Preparation of project plans for drug development and associated regulatory activities

Regulatory Submission Preparation

• Applications to conduct clinical research (IND, CTA)
• Applications to market a product (CTD, eCTD, NDA/BLA, NDS, MAA)
• Up-dating and maintenance of regulatory files, including responses to information requests from regulatory agencies

Due Diligence: Review of Regulatory Portfolio

• For the investor, or
• To help prepare for review by investor

Other

• Act as in-country regulatory contact for off-shore clients
• Scientific writing, including study reports