CROs offering Regulatory Affairs with Biologics (Other)
36 published
36 published CROs match Regulatory Affairs and Biologics (Other).
Locations in this set include United States, United Kingdom, China, Australia, India, and France.
Capabilities that show up most often in this set: Clinical Operations, Phase II Clinical Trials, Phase I Clinical Trials, Phase IV / Post-Marketing, and Data Management & eClinical.
Matching companies
Accelera SrlEurope-based preclinical CRO specializing in GLP-compliant toxicology, safety assessment, and efficacy testing for small molecules and biologics, with AAALAC accreditation and integrated translational research capabilities.
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.
AllucentAllucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies.
AltasciencesMid-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 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.
Atheln, Inc.Atheln provides customized strategic and operational consulting across product development, CMC, nonclinical, clinical, regulatory, and commercial services for pharma, biotech, and medtech clients.
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.
CelerionGlobal CRO specializing in early-phase clinical research and bioanalytical sciences with 650+ beds across 30 countries and 50+ years of experience.
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.
ChemPartnerGlobal 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.
ClarioClario 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 PharmaFull-service CRO delivering analytical, bioanalytical, and microbiology services across small molecules, biologics, gene therapy, and botanical drugs from discovery through clinical development.- Ergomed Clinical ResearchErgomed 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.
FortreaFortrea 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 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.
Innovate ResearchIndian CRO providing end-to-end clinical trial services (Phase I–IV), regulatory support, medical writing, biostatistics, data management, and biospecimen procurement across pharmaceuticals, biologics, medical devices, and nutraceuticals.
LabcorpLabcorp 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 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.
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