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.
Delivering Regulatory Insights For Success
Apply our knowledge and insights to plan and implement regulatory strategies for successful interactions with Regulatory Agencies.
Explore how we help prepare, write and defend your marketing applications with the global regulatory agencies.
Let our experts guide your regulatory agency interactions, from meeting preparation to relationship management.
We write clinical trial and regulatory documents tailored to meet the specific requirements of the product, therapeutic indication, and regulatory agency.