CMC Regulatory Submission Support CDMOs
121 published
121 published CDMOs match CMC Regulatory Submission Support.
Locations in this set include United States, United Kingdom, China, Germany, France, and India.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Gene Therapy, and Cell Therapy.
Matching companies
AGC BiologicsGlobal CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities.
ARSI Canada IncARSI Canada is a specialized CRO offering custom synthesis, API scale-up, analytical method development, and drug development services with over 50 years of combined experience and a GMP manufacturing facility in Bangladesh.
AbzenaFully integrated biologics and bioconjugates CDMO+CRO offering drug design, development, and GMP manufacturing for antibodies, ADCs, AOCs, RDCs, and vaccines from discovery through commercial scale.
Adragos PharmaGlobal CDMO headquartered in Munich offering end-to-end development and manufacturing for small molecules and biologics, including sterile/non-sterile liquids, solids, semi-solids, lyophilization, and prefilled syringes across seven facilities in Europe and Japan.
AdvaxiacGMP CDMO specializing in adenovirus vaccine development and manufacturing with a 100% batch approval rate and 10+ years of biologics expertise, serving major pharmaceutical and biotech clients.
Akron BioAkron Bio manufactures cGMP-compliant recombinant proteins, media, buffers, and transfection reagents for cell and gene therapy companies. Services span process development, fill-finish, and custom ancillary product manufacturing.
Akums Drugs and Pharmaceuticals Ltd.India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.
Alcami CorporationUS-based CDMO with 45+ years of experience providing integrated lab services, sterile and oral solid dose drug product manufacturing, and cGMP pharmaceutical storage and support services.
AldevronAldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization.
Almac GroupGlobal CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.
Altruist BiologicsGlobal CDMO offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates, with facilities in Suzhou and Hangzhou featuring up to 20,000-liter bioreactors.
Andelyn BiosciencesCDMO specializing in plasmid DNA and AAV viral vector manufacturing for cell and gene therapy, with digital-first platform emphasizing data integrity and collaboration.
Applied Pharmaceutical InnovationEdmonton-based not-for-profit offering integrated CDMO services in sterile fill-finish, oral solid dosage, topical application, and highly potent controlled substance manufacturing. Also provides CRO research, regulatory and quality, and clinical and quantitative support.
ArdenaArdena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.
Ascendia Pharmaceutical SolutionsAscendia is a specialty CDMO providing formulation development, analytical services, and GMP manufacturing for small molecules and biologics from pre-formulation through commercialization, with proprietary nanotechnologies including LipidSol, EmulSol, AmorSol, and NanoSol.- Asymchem LaboratoriesAsymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.
AxploraGlobal CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.- BSP PharmaceuticalsBSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.
BachemGlobal leader in peptide and oligonucleotide development and manufacturing, offering GMP-compliant clinical and commercial supply from early research through commercial scale.
Bend BioscienceU.S. pharmaceutical CDMO offering design, development, and manufacturing of oral solid and liquid dosage forms, from early formulation to commercial-scale production across three domestic locations.
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