Regulatory Due Diligence and Clinical Strategy Development

Situation:
A large medical device company needed help with regulatory and clinical due diligence to effectively position itself for decisions on a target technology acquisition.

Solutions:

  • Based on Halloran's competitive intelligence in the therapeutic area, the market, and emerging technologies, the company identified a target technology for acquisition.
  • Halloran evaluated the target product, a potential fast follower technology, by conducting a detailed regulatory precedence research, an extensive patent review, and competitive research on similar products.
  • Based on this extensive research, Halloran provided the company's executive team with a clinical and regulatory strategy, focusing on risk assessment, to develop the product for global approval.

Value:
Halloran's deep technology review, regulatory diligence expertise, and expert risk identification helped the company develop a robust evaluation plan to support their positioning on acquisition plans.