The FDA does not approve or certify sample suppliers, so a vendor claiming FDA certification should itself raise a question. What we deliver is the evidence an FDA reviewer expects to find behind your sample source: ethics committee approval of the collection protocol, the signed informed consent form, de-identified donor records with eligibility and serology screening, documented chain of custody from donor to vial, cell characterization and release testing, and a certificate of analysis for each lot. Sponsors file this material under the sample-source and CMC sections of an IND. Where a reviewer raises a specific question, we respond in writing with a supplementary statement.
