Innovation meets Regulation
We partner with biotech pioneers to bring life-changing therapies to patients. From early-stage discovery to commercialization, we handle the unique regulatory challenges of complex biological products.
Regulatory Strategy for Biologics
Navigating complex pathways for novel biologics and ensuring alignment with CBER/CDER requirements.
Biosimilar Development
Strategic guidance for 351(k) pathways, including comparability studies and interchangeability.
Cell & Gene Therapy Support
Specialized support for ATMPs, including INTERACT meetings and RMAT designations.
IND & BLA Submissions
End-to-end management of Investigational New Drug and Biologics License Applications.
Orphan Drug Designations
Securing incentives and exclusivity for therapies targeting rare diseases.