Regulatory Affairs, Operations and Consulting

Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

Whether you are at the beginning of your development program and need to prepare your regulatory strategy, are meeting with the agency preparing to file your IND/CTA, are entering your pivotal Phase 3 studies and need to have a discussion with the regulatory agency, or are preparing to submit a marketing application - our regulatory experts can help. Our teams have prepared over 160 marketing applications (NDAs, MAAs, jNDAs, NDSs, etc.) to date, of which over 80 have received regulatory approval so far.