Photo showing two people discussing regulatory challenges and complexities when manufacturing and working with the manufacturing of biologics and large molecules


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, Scorpius works closely with CDMO clients to develop effective regulatory drug development strategies for advanced biological therapies.

Service Offerings
  • Evaluate and guide regulatory strategy for biologics 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
Food and drug administration logo representing Scorpion's support with regulation around cell and gene therapy contract manufacturing
European medicines agency logo representing Scorpion's CDMO support with regulation around biologics contract manufacturing
PMDA logo representing Scorpion's global regulatory support in the large molecule manufacturing space