--- title: CROs offering US FDA Regulatory Strategy with Biologics (Monoclonal Antibodies) path: /explore/regulatory-us-fda/biologics-monoclonal-antibodies companies_count: 26 --- # CROs offering US FDA Regulatory Strategy with Biologics (Monoclonal Antibodies) 26 published CROs match US FDA Regulatory Strategy and Biologics (Monoclonal Antibodies). Locations in this set include United States, China, Australia, United Kingdom, Germany, and India. Capabilities that show up most often in this set: Regulatory Affairs, Biostatistics & Statistical Programming, Phase II Clinical Trials, Phase III Clinical Trials, and Data Management & eClinical. ## Matching companies - [Accelsiors](/companies/accelsiors) - Full-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. - [Allucent](/companies/allucent) - Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies. - [Aragen Life Sciences](/companies/aragen) - Global 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. - [BioAgilytix](/companies/bioagilytix) - Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually. - [BioDuro-Sundia](/companies/bioduro-sundia) - BioDuro-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. - [Certara](/companies/certara) - Certara 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. - [Clario](/companies/clario) - Clario provides comprehensive clinical trial endpoint solutions spanning cardiac safety, eCOA, medical imaging, respiratory, and precision motion analysis, supporting approximately 70% of FDA and EMA novel drug approvals over the past decade. - [Fortrea](/companies/fortrea) - Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success. - [Frontage Laboratories](/companies/frontagelab) - Global pharmaceutical development organization offering integrated drug discovery, preclinical safety/toxicology, DMPK, bioanalytical, and clinical trial services across 28 sites with 2,200 employees and 200+ FDA inspections. - [ICON plc](/companies/iconplc) - ICON 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. - [IQVIA](/companies/iqvia) - IQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes. - [Labcorp](/companies/labcorp) - Labcorp is a global life sciences and healthcare company providing diagnostic testing, drug development, nonclinical research, central laboratory services, and real-world data solutions to healthcare providers, health systems, and biopharma companies. - [MMS Holdings](/companies/mmsholdings) - Data-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. - [Medpace](/companies/medpace) - Full-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. - [Novotech](/companies/novotech-cro) - Global full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development. - [PPD](/companies/ppd) - PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific. - [PharmaLegacy Laboratories](/companies/pharmalegacy) - Preclinical 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. - [Pharmaron](/companies/pharmaron) - Premier 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 Research](/companies/premier-research) - Premier 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. - [Proone Labs](/companies/proonelabs) - Proone Labs provides preclinical pharmacology, drug discovery, and regulatory support services to biotech startups, traditional pharma, and in-silico companies. The team has delivered 30+ assays, 50+ cell lines, and supported 4 FDA drug approvals across multiple therapeutic areas.