Two layers. In China, collections run under hospital ethics approval and the national Human Genetic Resources rules, and our quality system is certified to ISO 9001 (certificate 001625Q, valid to February 2028); cell processing follows near-GMP controls and validated SOPs in a BSL-2 laboratory. For US and EU clients we map the same documentation to what ICH, FDA and EMA reviewers typically request, and our clinical work follows GCP. We also hold registration as a customs-registered consignor, so export clearance is handled on our side.
