Our sites in Colomiers and Gannat (France) are regularly inspected by ANSM (France) and by ANVISA (Brazil) and the Russian Federation, as well as other international authorities.
Our sites are regularly inspected by Chinese health authorities, the FDA (United States), ANVISA (Brazil), etc.
Yes. Unither has structured its services to support early-stage projects by strengthening R&D teams and providing regulatory support (strategy, drafting, and dossier preparation), as well as through our ability to produce very small volumes using pilot lines and dedicated tanks.
This enables us to help start-ups, biotechs, CROs, and development companies to safely conduct initial studies, right up to transfer to a BFS or multi-dose industrial site.
CMC regulatory support ensures your product and processes remain compliant with health authority requirements (EMA, FDA, ANVISA, etc.) throughout their lifecycle. At Unither, this support is provided by a dedicated regulatory affairs team within the Development, Quality, and Production teams. The service ensures the drafting and submission of dossiers (IMPD/IND, CTD/eCTD) goes smoothly, facilitates communication with authorities, and assists with post-authorization stages: variations, renewals, and audits.
