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.
In 2020, Veristat teams supported marketing applications for 10% of all FDA Novel Drug Approvals.
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.
Examine our publishing expertise to support the successful electronic submission of your regulatory documents.
Let our experts guide your regulatory agency interactions, from meeting preparation to relationship management.