CROs offering US FDA Regulatory Strategy with Small Molecule

Matching companies

• Aldeyra Therapeutics

  Biopharmaceutical company developing immunomodulatory therapies for immune-mediated ocular and systemic diseases, with late-stage clinical candidates targeting dry eye disease, allergic conjunctivitis, and retinal conditions.

• Allucent

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

• 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.

• 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

  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

  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

  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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• PPD

  PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.

• 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.

• ResolveMass Laboratories Inc.

  Canadian CRO and CDMO specializing in polymer synthesis, peptide characterization, and advanced analytical services for drug delivery and pharmaceutical development. FDA-registered and ISO 9001:2015 certified, serving North American pharmaceutical and biotech companies.

• 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.

• Tigermed

  Leading global CRO providing end-to-end clinical trial services, preclinical development, medical device and IVD trials, regulatory affairs, and real-world evidence studies across 180+ offices serving 4,000+ customers.

• 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.

• ethica CRO

  ethica CRO is the first contract research organization in the world to achieve HRPP accreditation from three distinct accrediting bodies, specializing in medical aesthetics, dermatology, and clinical trial management with a focus on ethical excellence and participant safety.