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
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.
Optimus Drugs Private LimitedLeading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities.
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.
PCI Pharma ServicesGlobal CDMO with 8,000+ employees across 38 GMP facilities offering sterile and non-sterile development, manufacturing, fill-finish, lyophilization, prefilled syringes, drug-device combinations, cold chain packaging, and clinical trial services.
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.
PI Health SciencesPI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.
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.
Pfizer CentreOneAward-winning CDMO specializing in commercial manufacturing of oral solids, sterile injectables, and biologic drug products with Pfizer's technical expertise and global network.
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.
Piramal Pharma SolutionsCDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.
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.
PolyPeptide GroupSpecialized global CDMO for peptide-based active pharmaceutical ingredients, supporting development and manufacturing of proprietary and generic APIs with expertise in peptide synthesis and GMP manufacturing.
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.
ProBioGen AGProBioGen AG is a CDMO offering cell line development, process development, GMP manufacturing and analytical services for proteins, antibodies, viral vectors and vaccines. It also provides technology platforms for biopharmaceutical manufacturing.
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.
Pyramid Pharma Services, Inc.Pyramid Pharma Services provides GMP drug product development and manufacturing for clinical and commercial programs, including formulation, lyophilization, stability studies, and analytical services.
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.
Rotop Pharmaka GmbHROTOP Pharmaka GmbH is a Dresden-based radiopharmaceutical manufacturer offering end-to-end CDMO services for radiopharmaceuticals, from early-stage development to commercial supply.
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.
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