Certifications, manufacturing licences and inspection record behind the platform's contract R&D and manufacturing work.
The credentials below are held by the platform's affiliated operating entity, which holds the medical device manufacturing licences and quality management system certifications under which all contract work is performed. The registrant always retains the registration certificate. Entity details, certificate numbers and validity dates are provided under NDA during partnership discussions.
In March 2023 the platform's first contract manufacturing project — a Class II active device — passed the drug administration's registration quality system inspection with zero findings. That inspection record is the basis on which subsequent registrants and hospital partners have engaged with the platform.
The platform has also supported a client product through TÜV CE certification for the European market.
Certificate numbers, validity dates and the licensed scope of each manufacturing licence are available on request under NDA. On nonclinical safety evaluation: the accreditation does not sit under the Seno.Bio name. GLP studies are carried out at the Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology, which belongs to the same national innovation system as the platform — this is an in-system capability, not an outsourced one. That centre issues the GLP report used in regulatory submission; the platform handles study design, organoid pre-screening and submission coordination.