CMC Regulatory Submission Support CDMOs in United States
62 published
62 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
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.
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.
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.
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.
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.
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.
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.
Boston Institute of Biotechnology, LLCFull-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L.
CMC Pharmaceuticals, Inc.CMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.- CRAMSNCRAMSN is a contract research, development, and manufacturing organization (CRO/CDMO/CMO) offering end-to-end solutions for drug substance and drug product development with GMP-certified facilities recognized by US, EU, Japan, and Canada regulatory authorities.
CambrexCDMO offering drug substance and drug product development, manufacturing, and analytical services across small molecules, peptides, and specialty chemistries.
CatalentGlobal CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.
CellaresCellares operates a global network of Smart Factories delivering integrated development and manufacturing (IDMO) services for cell therapies, with proprietary Cell Shuttle® and Cell Q™ platforms enabling cGMP-compliant, automated manufacturing and quality control at clinical and commercial scale.
CelularityCelularity is a clinical and commercial-stage biotechnology company specializing in off-the-shelf placental-derived allogeneic cell therapies and advanced biomaterial products.
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