Benuvia Operations Forms Integrated CRO–CDMO Platform with CCRP for Schedule I–V Therapeutics

COMPANY PROFILE
  • Benuvia Operations, LLC has entered a strategic partnership with Cannovation Clinical Research Partners to create an integrated platform combining controlled-substance manufacturing with clinical and regulatory services.
  • The collaboration aims to provide pharmaceutical and biotech sponsors with a unified pathway from early development through commercialisation for Schedule I–V therapeutics.

Benuvia Operations, LLC has formed a strategic partnership with Cannovation Clinical Research Partners to develop what the organisations describe as the industry’s first fully integrated manufacturing and contract research platform dedicated to Schedule I–V substances. The collaboration is designed to streamline development for cannabinoid, psychedelic and emerging CNS therapeutics by combining manufacturing, regulatory and clinical expertise within a single framework.

The partnership brings together Benuvia’s capabilities in controlled-substance manufacturing, analytical testing and CMC development with CCRP’s experience in preclinical and clinical research, regulatory strategy and global trial execution. According to the announcement, the joint platform is intended to offer sponsors a compliant route from early-stage development to commercial supply, addressing long-standing challenges caused by fragmented vendor ecosystems.

Benuvia stated that the integrated model aims to remove barriers that slow development by aligning GMP production with coordinated regulatory and clinical operations.

“Partnering with CCRP allows us to align GMP production with coordinated clinical and regulatory execution, eliminating many of the barriers that slow development and improving the speed and efficiency with which sponsors can advance these important medicines.”

Terry Novak, CEO of Benuvia

The organisations said the collaboration will support streamlined IND-to-trial transitions, reduced timelines through harmonised compliance standards, and access to global clinical trial networks across North America, Europe and Latin America. The platform includes DEA-licensed Schedule I–V manufacturing for compounds such as psilocybin, LSD and DMT, as well as commercialisation support.

As interest in psychedelic and cannabinoid-based treatments increases, Benuvia and CCRP state that the partnership positions them to meet rising demand for specialised infrastructure and compliance. Lisa Rich-Milan, CEO of CCRP, said the shared platform will enable a responsible and accessible route for advancing controlled-substance therapeutics.

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