Case study

Regulatory submissions and
pathway strategies

Challenge

A small company in stealth-mode asked Catalyst to serve as its regulatory team, responsible for building its regulatory strategy from the ground-up, preparing a submission pathway, and requesting/leading key FDA meetings (ex: INTERACT and Pre-IND).

Strategy

  • Recruited a former FDA OCE (Oncology Center of Excellence) senior leader and reviewer to manage the creation of a go to regulator strategy.
  • Identified, interviewed, and engaged additional external resources with significant expertise in the disease and technology areas of focus to serve as part of the regulatory team.
  • Produced a comprehensive Regulatory Information Management System (RIMS) to organize all clinical and regulatory information needed for company submissions to the Agency.
  • Prepared a submission pathway, timeline, and cost estimate for approval.
  • Worked with scientific team to prepare to request FDA meetings like INTERACT and Pre-IND meetings.

Impact

  • TBD

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