Regulatory Affairs Consulting

Responding To Regulatory Inspection Observations: Do’s and Don’ts

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 110 marketing applications (NDAs, MAAs, jNDAs, NDSs, etc.) to date, of which over 60 have received regulatory approval so far.