Regulatory Affairs

Comprised of former FDA senior-level managers, reviewers, and industry experts, our consultants provide provide solutions and guidance for each client’s regulatory problems or issues at the highest levels of efficiency and excellence.

• Advising on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs
• Preparing and/or assisting in the preparation and electronic submission of all types of regulatory documents
• Monitoring and tracking the ever-changing regulatory and technical environment to keep you ahead of the curve