CROs offering Regulatory Affairs with Biologics (Monoclonal Antibodies) in United States
14 matching organizations
Regulatory Affairs with Biologics (Monoclonal Antibodies) in United States is a frequent shortlist pattern for sponsors evaluating CRO partners with regional footprint. This page lists organizations that map to all three dimensions so you can move from broad taxonomy browsing to a geography-aware candidate set.
Profiles emphasize fit-first discovery: review scope, regulatory posture, and provenance on each listing rather than treating this page as a single ranked recommendation.
When you need additional filters (indications, claim status, or free-text search), continue to the main search experience and layer criteria on top of this starting point.
- Aliri Bioanalysis
Bioanalytical CRO specializing in PK/PD, biomarker, and spatial imaging services across discovery through Phase 3 clinical trials, with 20+ years of regulatory expertise.
- Aragen Life Sciences
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.
- BioDuro-Sundia
Integrated CRDMO with 30 years of expertise spanning discovery chemistry, biology, DMPK, and IND-enabling development for small and large molecules, plus API and drug product manufacturing.
- Celerion
Global CRO specializing in early-phase clinical research and bioanalytical sciences with 650+ beds across 30 countries and 50+ years of experience.
- 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.
- ChemPartner
Global preclinical CRO with 20+ years of experience supporting drug discovery through IND submission across small molecules and biologics, with 2,000+ scientists and facilities worldwide.
- Fortrea
Fortrea is a global Contract Research Organization (CRO) with over 30 years of clinical development expertise. The company delivers comprehensive Phase I through Phase IV study management, clinical pharmacology services, and market access solutions to biopharma, biotech, and…
- Medpace
Medpace is a full-service contract research organization (CRO) dedicated to accelerating the development of safe and effective medical therapeutics. The company operates under a therapeutically-focused, integrated model that provides sponsors with early and ongoing insight…
- PPD
PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific. The organization provides comprehensive drug development, laboratory, and lifecycle services to pharmaceutical, biotechnology, medical device,…
- 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
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.
- Syneos Health
Syneos Health is a comprehensive contract research organization (CRO) offering integrated clinical development and commercialization solutions for biopharmaceutical companies. ## Clinical Development Services The organization provides full-service clinical development…
- Syngene International
Innovation-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.
- Velocity Clinical Research
Integrated clinical research site organization operating 60+ sites across the U.S. and Europe, supporting trials that contributed to 61 FDA-approved products since 1986.
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