IND Filing Support CROs

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

Australian not-for-profit pharmaceutical company developing and registering medicines for neglected tropical diseases, providing regulatory and clinical development services for global health products.

Biosimulation and regulatory science company providing model-informed drug development, regulatory science consulting, and software solutions for the pharmaceutical industry.

Global regulatory affairs and drug development consulting firm providing IND/NDA/MAA filing support, clinical development strategy, and pharmacovigilance services.

German regulatory affairs consultancy providing EU regulatory strategy, marketing authorisation applications, and scientific advice for pharmaceutical and biotech sponsors.

Specialist CDMO for cell and gene therapy products offering GMP clinical and commercial manufacturing and development solutions for ATMPs from German, US, and Japanese facilities.

Independent pharmaceutical development services company in Basel providing drug formulation development, analytical development, and stability testing for injectable and biopharmaceutical products.

Specialized biometrics and regulatory CRO providing biostatistics, data management, medical writing, and regulatory strategy for pharmaceutical and biotech companies seeking FDA and EMA approvals.

Regulatory affairs and medical writing CRO providing IND/NDA/BLA preparation, regulatory strategy, and clinical documentation support for pharmaceutical and biotech companies.

Clinical pharmacology consulting firm specializing in PK/PD modeling, dose optimization, biosimilar development strategy, and regulatory science for pharmaceutical and biotech companies.

Japan's largest independent CRO providing end-to-end pharmaceutical development services including clinical operations, data management, regulatory affairs, and post-marketing surveillance across Asia.

China's largest independent CRO providing comprehensive clinical development services from preclinical through post-marketing with operations across China, Asia, and globally.

South Korean CRO providing Phase I-IV clinical development, bioanalytical services, and regulatory consulting with particular expertise in simultaneous MFDS-FDA-EMA regulatory submissions.

Full-service CRO based near FDA headquarters with 25+ years of regulatory and clinical trial expertise including adaptive designs, BE/BA studies, and pharmacovigilance.

US-based CRO specializing in rare disease and pediatric clinical trials, providing end-to-end trial management with deep expertise in orphan drug development and regulatory strategy.

European regulatory affairs and pharmacovigilance services provider offering end-to-end regulatory strategy, submission management, and post-authorization compliance for pharma and biotech companies.

Full-service CRO purpose-built for small and mid-size biotech, combining legacy of CATO Research, SMS Oncology, Pharm-Olam, and Nuventra into an integrated clinical development partner.

The only global full-service CRO focused exclusively on CNS drug development, with involvement in 22 FDA-approved CNS therapies across 13 indications.

Global tech-enabled full-service CRO with strength in government-sponsored trials, infectious disease, vaccines, ophthalmology, and rare disease clinical development.

Global regulatory consulting, pharmacovigilance, and clinical research organization providing single-source regulatory strategy, compliance, and medical information services.

Physician-led Australian CRO offering full-spectrum clinical and non-clinical services with AI-driven operating model across Phase I-III for innovative biotechs.

ASX-listed Taiwanese CDMO providing world-class API synthesis, finished dose form manufacturing, and clinical packaging from GMP facilities in the Southern Taiwan Science Park.

Clinical division of WuXi AppTec providing end-to-end Phase I-IV clinical trial services across China and Asia with expertise in NMPA, FDA and EMA regulatory submissions.

Parexel's Japanese arm offering full-service clinical development, regulatory consulting and market access services with deep PMDA submission expertise.

Munich-based mid-size CRO providing Phase I-IV clinical trial management, regulatory consulting, pharmacovigilance, and medical affairs across Europe and Asia.

UK-headquartered global mid-size CRO (now part of LabCorp/Covance) with deep expertise in oncology, rare diseases, and paediatric clinical trials across 30+ countries.

Oncology-focused CRO founded on the Mayo Clinic campus offering preclinical-to-clinical oncology development with PDX models, flow cytometry, and Phase I/II trial management.

Independent not-for-profit preclinical CRO offering full IND-enabling GLP toxicology programs, inhalation toxicology, and immunogenicity testing from the Illinois Institute of Technology campus.

Taipei-based drug development company and CRO specializing in oncology, running Phase I-III clinical trials for new cancer therapies and out-licensing proprietary pipeline assets.

Singapore-based global CRO consulting organisation assisting clients from clinical development through commercialisation with a focus on Asia-Pacific market access.

India-based integrated CDMO and CRO providing API R&D, formulation development, bioanalytical services, and Phase I-IV clinical research from facilities in Hyderabad.

Hyderabad-based mid-size CRO operating across India, the Philippines, Thailand, Vietnam, and the Middle East, providing Phase I-IV clinical trial services and regulatory affairs.

Nanjing-based clinical CRO and Pharmaron subsidiary providing one-stop clinical development services in China including regulatory affairs, clinical operations, pharmacovigilance, and bioanalysis.

Shanghai-based specialised clinical CRO providing full clinical development services in China and APAC with expertise in navigating NMPA regulatory pathways for multinational pharmaceutical companies.

Taiwan and China-focused CRO providing clinical development, regulatory strategy, and bioanalytical services with expertise in NMPA/TFDA dual-track submissions for sponsors entering Greater China.

US-Korea bridge CRO providing early-phase clinical and regulatory services tailored for Korean life science companies entering the US FDA pathway.

Full-service CRO headquartered in Dubai covering 31 countries across the Middle East and Africa with clinical operations, regulatory affairs, pharmacovigilance, and data management services.

CRO purpose-built for first-in-human clinical trials for MedTech, biopharma, and radiopharma startups across Latin America, operating in 10 countries.

Monterrey-headquartered CRO operating across Mexico, Argentina, Colombia, and Brazil with 20+ years of clinical research experience merging high-efficiency standards with academic scientific rigour.

US-based clinical-stage CRO arm specialising in endocrinology and cortisol-modulation therapeutics with expertise in Phase I-III metabolic and CNS clinical trials.

Full-service mid-size CRO specialising in rare diseases, transplantation, nephrology, and immunology across Phase I-IV trials.

Biostatistics-focused CRO and software company pioneering adaptive trial design, group sequential methods, and clinical trial simulation for pharma and biotech.

Life science regulatory and clinical development consultancy specialising in regulatory strategy, quality management, and organisational support for biotech and pharma.

Regulatory affairs and clinical development consultancy providing full-service FDA/EMA submission support, pharmacovigilance, and clinical trial management for small pharma and biotech.

Full-service CRO founded on biostatistics and data science excellence, supporting Phase I-IV trials across rare disease, immunology, and ophthalmology from Research Triangle Park.

Delhi-based Indian CRO providing regulatory and clinical trial management services across pharma, medical devices, and nutraceuticals.

Indian full-service CRO with offices in India, USA, UAE, and Hungary delivering Phases I-IV trials and real-world evidence studies across 18+ therapeutic areas.

Indian CRO affiliated with Dabur offering preclinical drug discovery, IND-enabling studies, and non-clinical research services from facilities near Delhi.

Pioneer Japanese CRO founded in 1982 providing one-stop pharmaceutical development services from early-phase through post-marketing activities in Japan and Asia.

Australian boutique CRO specialising in early-phase and first-in-human MedTech clinical trials across Australia, New Zealand, and the USA.

Australian CRO helping global pharma and biotech leverage the regulatory and cost advantages of clinical trials in Australia and New Zealand.

Retina-specialty CRO with offices across Latin America, Asia, and Australia supporting clinical trials in 18+ countries for ophthalmic and rare disease indications.

Regulatory consulting firm providing IND/NDA/BLA submission strategy, CMC consulting, and FDA interaction management for biotech and pharmaceutical sponsors.

Swiss/German full-service CRO providing Phase I-IV clinical trial management, regulatory consulting, and medical writing with offices across Germany, Austria, and Switzerland.

US-India hybrid CRO providing clinical trial management, regulatory affairs, pharmacovigilance, and medical writing with cost-effective offshore delivery from India.

Miami-based full-service CRO specialising in complex and rare disease clinical trials with deep regulatory expertise for accelerated and breakthrough therapy designations.

Mid-size global CRO under ALTEN Group formed by integrating Cmed and Larix, with deep oncology, rare disease, and cell/gene therapy clinical trial expertise across the US and Europe.

Fully integrated dermatology-dedicated CRO providing nonclinical through Phase III development services exclusively for skin disease products since 1997.

Full-service CRO integrating translational sciences, clinical pharmacology, bioanalysis, and regulatory strategy from preclinical through Phase IV development.

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

Cell and gene therapy CDMO with purpose-built cGMP facilities in Edinburgh and Hopkinton, Massachusetts, supporting clinical and commercial advanced therapy programs.

Global CDMO with integrated small molecule, biologics, and gene therapy manufacturing including proprietary viral vector platforms across the US, Europe, and Asia.

Gene therapy and viral vector CDMO in Columbus, Ohio, with 20+ years of leadership and 500+ GMP drug substance batches produced for rare and ultra-rare disease programs.

Innovation CRO purpose-built for medical device and IVD development, delivering integrated regulatory, clinical, and laboratory services across cardiovascular, neurological, and ophthalmic indications.

European specialist CRO and regulatory consultancy for IVD and medical device companies, with IVDR and MDR expertise across offices in Lisbon, London, Barcelona, and Madrid.

MedTech CRO formed by the 2020 merger of Regulatory and Quality Solutions and Maetrics, delivering 40+ years of medical device regulatory, clinical, laboratory, and reimbursement expertise.

Canadian Phase I and bioequivalence CRO with a 150-bed clinical facility in Toronto and over 2,500 completed BA/BE and early-phase studies for global pharma clients.

Dr. Reddy's wholly-owned integrated CRO and CDMO for small molecules and biologics, combining 650+ Indian scientists with GMP manufacturing in the UK, Mexico, and India.

Employee-owned Canadian scientific and regulatory toxicology consultancy with 35+ years advising FDA, EMA, and Health Canada submissions for pharma, biotech, and chemical companies.

GLP-compliant preclinical CRO in Austin, Texas, offering 100+ validated xenograft efficacy models, IND-enabling toxicology, and RNAi therapeutic development services.

Durham-based CDMO using proprietary ARCUS genome editing technology to develop and manufacture next-generation allogeneic cell and gene therapy programs.