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Good People Working on Good Projects with Good Process

Case Study 1: Regulatory Submissions

Situation Start-up pharmaceutical company needed regulatory to bring a drug to market.
Frestedt Approach
  • Formulated and negotiated generic drug regulatory strategy for 505(b)(2) submission
  • Devised novel combination regulatory product plan to limit testing for kitted products
  • Obtained data from competing companies manufacturing the same drug/device combination product
  • Updated and trained in-house staff on quality system improvements, including new device testing requirements
  • Marketed a new convenience kit
Results Frestedt provided both in-house and virtual regulatory support/strategy to successfully bring generic drug and convenience kits to market — one of the first product approvals for a combination drug/device manufactured by competing companies.

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