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Manufacturing

Regulatory Support

Biologics product development brings regulatory challenges and complexities that are foreign to traditional pharmaceutical development process. From the early stages of product development through to market authorization, Scorpion works closely with clients to develop effective regulatory drug development strategies for advanced biological therapies.

Service Offerings
  • Evaluate and guide regulatory strategy for product development
  • Represent clients in interactions with FDA or other regulatory agencies
  • Author and review CMC materials for regulatory applications and submissions
  • Leverage experience with global regulatory agencies including FDA, EMA, PMDA
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