CROs offering Regulatory Affairs (CRO)

Matching companies

• Accelera Srl

  Europe-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.

• Acromion Gmbh

  European full-service CRO supporting clinical development from Phase I to IV and non-interventional studies, with expertise in clinical monitoring, data management, biostatistics, medical writing, and regulatory affairs.

• Advanced Clinical

  Global CRO and FSP provider with 25+ years of experience delivering integrated clinical research solutions across North America, Europe, LATAM, and APAC.

• 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.

• Allucent

  Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies.

• 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.

• Alturas Analytics

  GLP-compliant bioanalytical CRO specializing in LC-MS/MS solutions for preclinical and clinical research, IND submissions, and new drug applications.

• 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.

• Avion

  Full-service CRO specializing in clinical trial management, advanced medical imaging, dosimetry, and data management across oncology, dermatology, and radiopharmaceutical therapies.

• Beaufort

  Beaufort is a MedTech-specialized CRO offering clinical operations, regulatory strategy, and submission support tailored to device and diagnostic innovations across all therapeutic areas.

• BioAgile Therapeutics

  ISO 9001:2015-certified CRO offering end-to-end clinical research services including Phase I–IV trials, medical writing, biostatistics, data management, and regulatory support across pharmaceuticals, nutraceuticals, devices, and biotech.

• 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.

• Broughton Group

  Global CRO with over 15 years of experience in analytical testing integrated with scientific consultancy and regulatory compliance support across all stages of pharmaceutical development.

• CTI Clinical Trial and Consulting Services

  Full-service CRO founded in 1999 providing therapeutic expertise across clinical trial and consulting services to pharmaceutical and biotechnology companies.

• Cadena Research

  Cadena Research is a CRO specializing in preclinical development of radiopharmaceuticals, offering laboratory services, radiochemistry expertise, regulatory guidance, and scientific advisory support to accelerate drug development and approval.

• Caidya

  Caidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research.

• 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.

• ClinActis Pte Ltd

  Full-service CRO delivering clinical trial services across Asia Pacific, with 50+ years of cumulative experience managing Phase I–IV trials and expertise in oncology, cardiovascular, CNS, and infectious disease indications.

• Clinical Research Network India Pvt. Ltd.

  Clinical Research Organization offering Phase I–IV clinical trials, pharmacovigilance, medical writing, regulatory affairs, and data management services with 15+ years of experience across cardiology, oncology, vaccines, and medical devices.

• Clinilabs

  Clinilabs is the leading CNS-focused CRO with 25+ years of expertise in neurotherapeutic clinical trials, offering Phase 1–4 trial management, early-phase development, clinical research units, and MedTech device expertise across psychiatry, neurology, substance use, and rare CNS disorders.

• CovarsaDx

  CovarsaDx provides full-service clinical research, regulatory consulting, and quality assurance for IVD and medical device trials, with expertise in FDA 510(k), De Novo, and PMA pathways.

• Critical Path Institute

  Critical Path Institute convenes pharmaceutical, government, patient, and academic organizations to optimize drug and medical product development through collaborative consortia, regulatory science initiatives, and clinical trial design optimization.

• Datavant

  Datavant operates the largest health data network in the U.S., providing secure, compliant data connectivity and real-world data solutions to life sciences, health plans, providers, and legal/insurance organizations.

• ERGOMED Group

  Global, full-service CRO specializing in oncology and rare disease clinical development, with complementary pharmacovigilance and QA consulting brands.

• Emerald Clinical

  Global CRO with 25+ years of experience and world-renowned renal expertise, offering end-to-end clinical trial services across renal, oncology, cardiovascular, and early-phase research with operations spanning 70+ countries.

• 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.

• ExperTrials

  European-based full-service CRO supporting biotech and medtech companies from Phase I through Phase IV and market access, with 80+ senior clinical research associates across Europe and the USA.

• Fortrea

  Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.

• Frontage Laboratories

  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.

• 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.

• Global Clinical Research

  Full-service CRO based in Nepal specializing in Phase III & IV clinical trial management, regulatory affairs, medical writing, and clinical data management for pharmaceutical, biotechnology, and medical device companies globally.

• ICON plc

  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

  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.

• Indero

  Indero is a dual-focus CRO specializing in dermatology and rheumatology clinical trials, offering end-to-end services from early to late phase with global capabilities across North America, Europe, Latin America, and Asia-Pacific.

• Inizio Ignite

  Strategy, research, clinical development, and transformation consulting for biopharma. Combines Putnam, Research Partnership, STEM, and Vynamic to deliver end-to-end expertise from pipeline to launch.

• Innovate Research

  Indian 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.

• JSS Medical Research

  Full-service CRO with over 30 years of experience offering clinical trials, biostatistics, medical writing, and health economics services across all phases of development.

• Krescent Medical Research

  Full-service preclinical and clinical CRO supporting pharmaceutical, biotechnology, and medical device companies with trial design, site selection, data management, statistical analysis, and medical writing across Asia-Pacific.

• Labcorp

  Labcorp is a global life sciences and healthcare company offering diagnostic testing, clinical laboratory services, and biopharma support. Labcorp Early Development Services supports nonclinical research, central laboratory work, and early-phase development for drug programs.

• Lindus Health

  Lindus Health is a clinical research organization delivering end-to-end trial execution across Phase 1–2a programs with proprietary AI-driven patient recruitment, integrated site networks, and performance-based pricing. The company has completed 45+ trials with 82% on-time enrollment and operates across the US, UK, and Europe.

• Linical

  Global, award-winning CRO guiding clinical development from early-phase research to large-scale global studies with 90% client retention.

• Lotus Clinical Research

  Specialized CRO supporting clinical development in neuroscience and metabolic disease across all phases, with direct access to 20 wholly-owned US research sites and 400+ beds.

• MMS Holdings

  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.

• Medidata Solutions

  Medidata provides a unified clinical trial platform with AI-driven data management, electronic data capture, patient engagement tools, and real-world data integration to accelerate research across all trial phases.

• 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.