China GLP Laboratory Resources — Pharmaceutical & Medical Device
MTL maintains a network of pre-qualified, China GLP-accredited laboratories covering both pharmaceutical and medical device testing standards — with reports formatted to meet NMPA, US FDA, and EU MDR requirements.
Pharmaceutical GLP Services
Pre-clinical studies for drug candidates, biologics, and therapeutic agents. Includes toxicology, pharmacokinetics (PK), pharmacodynamics (PD), and safety assessment studies conducted to NMPA and international GLP standards.
Medical Device GLP Services
Biocompatibility testing (ISO 10993), toxicology studies, material safety evaluations, device performance testing, and sterility/endotoxin validation. All reports meet China NMPA regulatory requirements for medical device registration — supporting the technical documentation stage of NMPA registration.
Dual-Market Value
GLP reports generated by our partner laboratories are formatted to meet both China NMPA requirements and international regulatory standards (US FDA, EU MDR, etc.), providing significant dual-market value. This accelerates global regulatory approvals while establishing China market credentials.
Frequently Asked Questions
Does MTL cover both pharmaceutical and medical device GLP?
Yes. MTL maintains a network of pre-qualified, China GLP-accredited laboratories covering both pharmaceutical and medical device testing standards, including pharmacokinetics/pharmacodynamics studies, toxicology, and ISO 10993 biocompatibility testing. Typical turnaround is 8–16 weeks depending on study scope and complexity.
Can GLP reports from China be used for FDA or EU MDR submissions?
GLP reports generated by MTL's partner laboratories are formatted to meet both China NMPA requirements and international regulatory standards (US FDA, EU MDR, etc.), providing dual-market value for manufacturers pursuing multiple markets.
How does GLP testing fit into the overall China market entry timeline?
GLP studies typically run alongside or ahead of the technical documentation stage of NMPA registration — see NMPA Registration & Licensing for how the full regulatory pathway fits together.
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