Expert CDMO for chemistry-based medical devices under ISO 13485 We manage the entire lifecycle, from synthesis to Phase I-III clinical supply and commercial scale, ensuring full compliance with FDA and EMA standards for market entry.
Aseptic manufacturing in ISO 5 cleanrooms for sterile drugs and devices. Services include lyophilization and sterile fill-finish, providing full cGMP support from clinical trials through to successful commercial distribution.
Specialized cGMP CDMO for liposomal and nano lipid-based formulations and drug delivery systems. We enhance solubility for complex molecules in drugs and devices, providing the technical and regulatory pathway from development to full commercialization.
Tailored process chemistry for NCEs and pro-drugs. We optimize synthetic routes and ensure seamless tech transfer, building validated cGMP manufacturing pathways designed for your product's long-term commercial success and regulatory approval.
