CMC Regulatory Submission Support CDMOs in United States
64 published
64 published CDMOs match CMC Regulatory Submission Support in United States.
Locations in this set include United States, United Kingdom, China, Japan, Germany, and Italy.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Cell Therapy, and Gene Therapy.
Matching companies
LifecoreLifecore is a sterile injectable CDMO with 60 years of regulatory experience, offering end-to-end services including formulation and process development, aseptic manufacturing, fill-finish, analytical testing, stability, and assembly and packaging for drugs, biologics, medical devices, and combination products.
Made ScientificCell therapy CDMO offering end-to-end development, GMP manufacturing, and regulatory support from preclinical through commercial scale, with specialized expertise in T cells, NK cells, MSCs, iPSCs, and other cell modalities.
Northway BiotechEnd-to-end CDMO specializing in protein-based biologics and gene therapies, with 20+ years of expertise and cGMP facilities in Lithuania and Massachusetts supporting development from preclinical to commercial stages.
Onyx ScientificSmall molecule CDMO specialising in process chemistry, solid-state chemistry, and API manufacturing for Phase I–III and commercial supply. Licensed for commercial API production at its Sunderland, UK facility, with a second site in North Carolina, US.
Oxford BiomedicaGlobal viral vector CDMO with 30 years of expertise in lentivirus, AAV, and adenovirus manufacturing. Provides end-to-end development and GMP-compliant manufacturing services from preclinical through commercial launch for cell and gene therapy programs.
PHT International, Inc.PHT International is a Contract Research, Development, and Manufacturing Organization (CRDMO) offering small-molecule process R&D, cGMP manufacturing from milligrams to multi-tons, and chemical sourcing with global facilities across North America, Europe, and Asia.
Patheon (Thermo Fisher Pharma Services)Patheon is a trusted global contract development and manufacturing organization (CDMO) partner owned by Thermo Fisher Scientific, offering 360° integrated solutions from early-stage R&D through clinical supply and commercial manufacturing.
PharmaBlockLeading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.
PharmaronPremier 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.
PluriFull-service CDMO specializing in cell therapy manufacturing with GMP facilities, proprietary packed-bed expansion technology, and regulatory approvals from FDA, EMA, PMDA, and other key agencies for clinical-stage production.
Porton AdvancedEnd-to-end ATMP CDMO provider offering cell engineering, lentiviral vectors, mRNA/LNP, plasmid development, and GMP manufacturing from preclinical through commercialization with 24 IND approvals across NMPA, FDA, and MedSafe.
Pyramid Pharma ServicesUS-based aseptic fill-finish CDMO specializing in parenteral biologics, peptides, and small molecules from development through commercial supply, with formulation, analytical, stability testing, and vial/syringe/cartridge filling capabilities.
Quotient SciencesIntegrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.
SCTbioSCTbio is a European cell and gene therapy CDMO offering cGMP manufacturing, lentiviral and gammaretroviral vector production, analytical development, and QP batch release. Its facilities include 420 m² of Class A/B/C GMP cleanrooms, and it reports more than 2,000 GMP batches manufactured.
SK pharmtecoSK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.- STC BiologicsBoutique biologics CDMO with a Speed-to-Clinic platform spanning royalty-free cell line development through cGMP drug substance, in as little as 12 months. Runs a single-use mammalian GMP suite in Newton, MA for antibody, bispecific, and ADC programs.
Sai Life SciencesIntegrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients.
Samsung BiologicsLeading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
Simtra BioPharma SolutionsSimtra BioPharma Solutions is a CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and bioconjugation services for clinical and commercial products.
Sterling Pharma SolutionsSmall molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation.
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