NDA/BLA Support CROs

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

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.

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.

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

Global real-world evidence and outcomes research firm providing observational studies, health economics, market access, and regulatory evidence generation for pharma and biotech.

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

IQVIA's Japanese subsidiary providing clinical operations, real-world data analytics, regulatory strategy and technology solutions with one of the largest clinical operations teams in Japan.

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.

South Korea's first CRO founded in 1997, providing comprehensive Phase I-IV clinical development solutions including regulatory affairs, data management, pharmacovigilance and medical translation.

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.

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.

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

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.

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.

Cambridge-based specialty CRO focused on biostatistics, statistical programming, clinical data management, and regulatory submission support for pharma and biotech.

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

Lithuanian regulatory affairs consultancy providing EU regulatory strategy, marketing authorisation applications, pharmacovigilance, and medical writing across 30+ European markets.

Consulting arm of Syneos Health providing commercial and regulatory advisory, launch planning, and market access strategy for pharmaceutical and biotech clients.

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

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.

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

US-based biomanufacturing CDMO founded in 2020 delivering end-to-end development and manufacturing for biologics, mRNA, and cell and gene therapy across a domestic facility network.

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.

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.