NMPA-Experienced CROs

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Leading global pharmaceutical and medical device open-access capability and technology platform. WuXi AppTec provides services spanning from discovery through manufacturing across small molecules, biologics, and cell/gene therapies.

Preclinical ADME and pharmacokinetics CRO in Pennsylvania providing in vitro and in vivo absorption, distribution, metabolism, and excretion studies as part of Pharmaron's global network.

Preclinical ADME and pharmacokinetic service provider now part of Pharmaron. Specializes in in vitro and in vivo DMPK, drug transporter studies, and metabolite identification.

Chinese CDMO providing pharmaceutical development and manufacturing services from drug discovery to commercialization, known as a long-term supplier to major pharmaceutical companies including Pfizer.

Chinese CDMO specializing in custom synthesis of building blocks, advanced intermediates, and reference compounds for global pharmaceutical R&D, with a catalog of over 40,000 compounds.

Global CRO/CDMO providing integrated drug discovery and development services including medicinal chemistry, ADME/PK, pharmacology, and process chemistry from US and China operations.

Shanghai campus of BioDuro-Sundia providing integrated discovery and development services including medicinal chemistry, DMPK, biology, and preclinical development for global biotech.

Japan's largest independent CRO providing end-to-end pharmaceutical development services including clinical operations, data management, regulatory affairs, and post-marketing surveillance across Asia.

Nanjing-based clinical CRO and Pharmaron subsidiary providing one-stop clinical development services in China including regulatory affairs, clinical operations, pharmacovigilance, and bioanalysis.

China-based global CRO providing full clinical development services from Phase I through IV with strong site networks across China, Korea, and Southeast Asia.

Biosimulation and regulatory science company providing model-informed drug development, regulatory science consulting, and software solutions for the pharmaceutical industry.

Shanghai-headquartered CRO/CDMO offering integrated drug discovery chemistry, biology, and biologics development services including ADC and recombinant protein production.

Singapore-founded full-service CRO with operations across 12 Asia-Pacific markets, offering clinical trial management, regulatory affairs and data services.

Taiwan and China-focused CRO providing clinical development, regulatory strategy, and bioanalytical services with expertise in NMPA/TFDA dual-track submissions for sponsors entering Greater China.

Global full-service CRO founded in 1995 with strong Asia-Pacific and European presence, expanded via acquisition of CROMSOURCE for deeper European clinical operations.

Labcorp Drug Development's Chinese laboratory providing preclinical safety assessment, bioanalytical services, and clinical trial support for NMPA regulatory submissions.

Translational oncology and metabolic disease CRO providing tumor models (PDX, syngeneic, humanized), oncology pharmacology, and biomarker services for drug discovery.

Chinese CRO-turned-biotech providing clinical development services with deep oncology expertise, operating a portfolio of discovery through Phase III programs in solid tumors and hematological malignancies.

South Korean full-service CRO providing clinical development services from Phase I through post-marketing with bioanalytical capabilities and strong ties to Korean academic medical centers.

Japanese CRO group providing clinical development, data management, biostatistics, and regulatory affairs services across Japan, China, Korea, and Southeast Asia.

Shanghai-based preclinical CRO providing in vivo pharmacology, toxicology, DMPK, and bioanalytical services with specialized PDX platforms for oncology drug development.

CRO providing integrated drug discovery and development services including ADME/PK, bioanalytical, CMC, and clinical services with operations in the US and China.

Chinese operations of Frontage Laboratories providing bioanalytical services, ADME/PK studies, and analytical chemistry from GLP-compliant laboratories in Shanghai and Suzhou.

Shanghai-based specialised clinical CRO providing full clinical development services in China and APAC with expertise in navigating NMPA regulatory pathways for multinational pharmaceutical companies.

Chinese CRO and CDMO offering integrated preclinical biology, in-vitro pharmacology, and early drug discovery services for domestic and multinational pharma clients.

Chinese pharmaceutical company providing contract research and clinical development services for pharmaceutical companies seeking NMPA approvals in China.

Global clinical research and health data analytics company formed from the merger of IMS Health and Quintiles. Offers end-to-end clinical development, real-world evidence, and technology solutions.

Chinese preclinical CRO providing GLP-compliant safety evaluation, pharmacokinetics, efficacy studies, and drug metabolism studies with comprehensive NHP and rodent capabilities.

Integrated drug discovery and development services company providing medicinal chemistry, ADME/DMPK, pharmacology, and clinical research from India, US, and China operations.

Chinese integrated drug discovery and development CRO providing medicinal chemistry, ADME/PK, pharmacology, toxicology, and CMC services from Shanghai operations.

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

Greater China operations of Australian CRO Novotech, providing full-service clinical trial management across mainland China, Hong Kong and Taiwan with NMPA submission expertise.

PPD's Chinese clinical operations providing Phase I-IV clinical development, regulatory strategy, and site management for multinational and domestic pharmaceutical companies in Greater China.

Integrated pharmaceutical R&D service platform offering drug discovery, preclinical, clinical, and commercial manufacturing services to biotech and pharma companies globally.

Chinese CDMO providing API development and manufacturing services including custom synthesis, process development, and commercial-scale production from multiple GMP-certified facilities.

ASX-listed Taiwanese CDMO providing world-class API synthesis, finished dose form manufacturing, and clinical packaging from GMP facilities in the Southern Taiwan Science Park.

One of China's earliest chemistry-focused CROs offering integrated drug discovery, DMPK, and pharmaceutical development services globally.

Leading Chinese gene therapy CDMO providing lentiviral, adenoviral, and AAV vector manufacturing services along with custom cell line development for preclinical and clinical-grade production.

Chinese CRO and CDMO providing drug discovery chemistry, DMPK, analytical services, and clinical trial manufacturing from Shanghai and Chengdu operations.

China's largest independent CRO providing comprehensive clinical development services from preclinical through post-marketing with operations across China, Asia, and globally.

Chinese CRO/CDMO providing integrated drug discovery services including structure-based drug design, medicinal chemistry, ADME/PK studies, and biologics development from Shanghai operations.

WuXi AppTec's cell and gene therapy division providing GMP viral vector manufacturing, cell therapy manufacturing, and plasmid DNA production from US and China facilities.

Global biologics CDMO providing end-to-end solutions for biologics drug development and manufacturing including monoclonal antibodies, bispecific antibodies, ADCs, and cell and gene therapies.

Clinical division of WuXi AppTec providing end-to-end Phase I-IV clinical trial services across China and Asia with expertise in NMPA, FDA and EMA regulatory submissions.

WuXi AppTec's pharmaceutical development and manufacturing arm providing API process development, formulation development, analytical services, and GMP manufacturing from China and US facilities.