Anson Group helps non-U.S. clients to avoid potentially costly delays by maximizing the effectiveness of their critical communications with FDA.

A large, multinational company, based in Europe, requested advice on approaching the FDA with a briefing document involving critical issues that could deliver a more rapid development of their product. Anson Group responded to provide:

• A prompt review and independent critique of the client’s draft document

• Specialized expertise that was needed to validate the proposal

• Additional essential commentary based on Anson expertise in CMC and regulatory areas of pharmaceutical development

• Document editing based on Anson’s experience in effective communication with FDA

The resulting final document was sufficiently clear and effective that FDA deemed a previously scheduled formal meeting to be unnecessary and approved the proposal. The company cancelled flight arrangements and was able to move to the next step.

  Upon contact, the client received immediate senior level attention from the Anson Group. The nimble response of the Anson team provided quick, insightful and effective advice to the client.