CROs offering China NMPA Regulatory Strategy with Biologics (Monoclonal Antibodies)
17 published
17 published CROs match China NMPA Regulatory Strategy and Biologics (Monoclonal Antibodies).
Locations in this set include United States, China, Australia, India, United Kingdom, and Mexico.
Capabilities that show up most often in this set: US FDA Regulatory Strategy, Regulatory Affairs, EU EMA Regulatory Strategy, Japan PMDA Regulatory Strategy, and Biostatistics & Statistical Programming.
Matching companies
AccelsiorsFull-service CRO providing clinical trial management, regulatory consulting, pharmacovigilance, biostatistics, and medical writing across 40+ countries with AI-secure eClinical systems and patient-centered trial design.
Aragen Life SciencesGlobal CRDMO partner offering integrated discovery-to-commercialization services across small molecules and biologics, with 4000+ scientists and R&D/manufacturing campuses in Asia, North America, and Europe.
BioDuro-SundiaBioDuro-Sundia is a contract research, development, and manufacturing organization (CRDMO) with 30 years of expertise providing integrated drug discovery, development, and manufacturing services from target identification through IND submission.
CertaraCertara transforms drug development with proprietary biosimulation software, predictive modeling, and AI-driven services spanning discovery through commercialization. Serving 2,400+ biopharmaceutical companies and regulatory agencies across 70 countries, Certara's model-informed drug development (MIDD) platform accelerates clinical and regulatory decision-making.
FortreaFortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.
ICON plcICON is a global clinical research organization providing full-service drug development and clinical trial solutions across early phase through post-marketing, including clinical operations, bioanalytical labs, cardiac safety, medical imaging, and regulatory affairs.
IQVIAIQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes.
MMS HoldingsData-focused CRO providing full-spectrum biometrics, regulatory submissions, safety & risk management, and therapeutic expertise across oncology, CNS, rare diseases, and psychedelics. Named Best Specialist CRO at the Scrip Awards with zero refusals to file on 50+ marketing applications in five years.
MedpaceFull-service CRO with 30+ years of organic growth, offering integrated clinical development services across all phases with wholly-owned central labs, bioanalytical lab, imaging core lab, and Phase I unit.
NovotechGlobal full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development.
PPDPPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.
PharmaLegacy LaboratoriesPreclinical CRO with over 1,500 validated in vivo efficacy models spanning 100+ indications in oncology, immunology, inflammation, and bone disease. AAALAC-accredited vivarium with capacity for 30,000 rodents and 350 non-human primates supports IND filings to FDA and CFDA.
PharmaronPremier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
Premier ResearchPremier Research is a global full-service CRO delivering clinical research and development solutions across the complete drug development lifecycle. The organization provides comprehensive capabilities spanning study design, study startup, medical affairs, biostatistics and data management, central monitoring, clinical monitoring and site management, project and risk management, safety and pharmacovigilance, quality and compliance, and medical writing.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
TigermedLeading global CRO providing end-to-end clinical trial services, preclinical development, medical device and IVD trials, regulatory affairs, and real-world evidence studies across 180+ offices serving 4,000+ customers.
WuXi AppTecGlobal CRDMO platform providing integrated end-to-end contract research, development, and manufacturing services across discovery, preclinical, clinical, and commercial phases for small molecules, peptides, oligonucleotides, and biologics across 30+ countries.
Markdown mirror: /explore/regulatory-china-nmpa/biologics-monoclonal-antibodies.md