FDA DRUG & MEDICAL DEVICE ADVISORY COMMITTEE REVIEW

Millions of dollars are riding on your FDA Advisory Committee meeting. Any misstep can affect approval likelihood and timing. Be prepared. Innovative Science Solutions (ISS) can help ensure a timely approval by providing an integrated approach to managing all aspects of an FDA Advisory Committee meeting for your product. We provide a one-stop solution for all the mission critical elements and deliver unmatched services.

ISS is involved in more FDA Advisory Committee meetings per year than even the largest pharmaceutical companies.

REGULATORY STRATEGY, SUBMISSIONS & MEETINGS

ISS specializes in providing insight and knowledge of the regulatory process as well as integrated approaches that maximize the potential for success while minimizing approval time. ISS helps to prepare persuasive regulatory submissions based on sound scientific data. This includes the design and development of INDs, IDEs, 510(k)s, NDAs as well as comprehensive scientific substantiations for product claims.

 

RX – OTC Switch: ISS is a leader in pursuing the most challenging, cutting edge RX – OTC switches, and achieves this through a robust understanding of the dynamic between consumers, regulators, investigators, and the medical community.

 

Issue Management / Outreach Programs: ISS builds initiatives and outreach programs that facilitate product acceptance and market success, as well as influence prescribing behavior.

REGULATORY RESOURCES

Essential Guide to
FDA White Oak Meetings
Roadmap to
AdCom Success