From Lab Through Launch: Your Partner At Every Step

Simtra BioPharma Solutions offers end-to-end CDMO services focused exclusively on sterile injectables, partnering with clients from lab to launch. Their quality-driven approach is designed to streamline transitions, maximize yield, minimize loss, and reduce risk, ultimately accelerating a product's speed to market.

The service continuum spans the full drug product development, manufacturing, and analytical spectrum, supporting phases from Development/Pre-Clinical through Process Validation for BLA/MAA support. Simtra emphasizes developing robust formulations early to minimize late-stage setbacks and ensure smooth progression into clinical studies. Key offerings include formulation development, lyophilization feasibility/optimization via an industry-leading Center of Excellence, non-GMP and clinical batch manufacturing, and rigorous ICH stability testing. By integrating expertise and focusing on manufacturability from the start, Simtra aims to de-risk clinical supply and ensure commercial readiness and regulatory compliance.