CROs offering Regulatory Affairs with Biologics (Other)

Regulatory Affairs combined with Biologics (Other) is a common shortlist filter for sponsors evaluating CRO partners. This explore page lists organizations that publicly map to both dimensions, so you can move from taxonomy browsing to a tighter candidate set without rebuilding filters from scratch.

Profiles here are fit-first: open each listing for scope, geography, regulatory posture, and provenance-backed facts. The directory does not rank these rows as a single "best" answer — use them to assemble a right-sized outreach list for your program stage and quality bar.

When you need adjacent criteria (indications, claim status, or cross-category search), continue to the main search experience and layer filters on top of this service × modality starting point.

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Matching companies

Allucent
Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies. With over 30 years of background in regulatory trends, therapeutic experience, and operational expertise, the company partners with biopharma to advance…
Altasciences
Mid-size early phase CRO/CDMO in Canada and the U.S. offering preclinical safety testing, clinical pharmacology (Phase I–II), bioanalysis, research services, and manufacturing with integrated capabilities.
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.
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.
Emery Pharma
Full-service CRO delivering analytical, bioanalytical, and microbiology services across small molecules, biologics, gene therapy, and botanical drugs from discovery through clinical development.
Ergomed Clinical Research
Ergomed is a specialized CRO with 25+ years of experience delivering oncology, rare disease, and complex clinical trial solutions across all phases globally, backed by a team of 100+ MDs and PhDs.
Fortrea
Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.
Genevoyager (Wuhan) Co., Ltd.
Leading CRO/CDMO provider specializing in viral vectors, proteins, and vaccines with proprietary AAV manufacturing technology and cGMP-grade facilities operational since October 2023.
ICON
ICON is a CRO with 8,000 biotech-dedicated professionals offering end-to-end clinical development, consulting, and therapeutic expertise across all development phases.
ICON plc
ICON is a world-leading clinical research organization providing outsourced services across the full clinical trial lifecycle, from early phase through commercialization, to pharmaceutical, biotechnology, and medical device 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
Labcorp Early Development Services is part of Labcorp, a global life sciences and healthcare company offering integrated drug development and diagnostic services. The organization supports nonclinical research, central laboratory services, early phase development, regulatory…
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
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.
Nuvisan
Full-service CRO and CDMO with specialized competency centers in drug discovery, formulation development, GMP manufacturing, and bioanalytical services across Germany and France.
Oncodesign Services
Contract research organization specializing in drug discovery and preclinical services for oncology, inflammation, and infectious diseases since 1995.
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.
Simbec-Orion
Full-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology.
Syneos Health
Global CRO with 26,000+ employees offering integrated clinical development, regulatory affairs, and commercialization services. Helped develop or commercialize 96% of FDA-approved oncology drugs and 93% of EMA-authorized oncology products in the last five years.
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.
TFS HealthScience
Global mid-size CRO specializing in dermatology, internal medicine, neuroscience, oncology, and ophthalmology with Phase I-IV clinical development, real-world evidence studies, and flexible resourcing solutions across 600+ experts in Europe, North America, and Australia.
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.
WuXi AppTec
Global 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.

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