Strategy & Planning

• Development of regulatory strategies
• Assessment of existing regulatory strategies and timelines
• 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 (NDA/BLA, NDS, MAA)
• Updating 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 a review of your portfolio by investor(s)

Other

• In-country regulatory contact for off-shore clients
• Scientific writing, including study reports