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, 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

Services