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
Charles River LaboratoriesCharles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years.
CodisGlobal CDMO specializing in commercial-scale spray drying, amorphous solid dispersions, microencapsulation, and continuous granulation with 400,000 sq ft of GMP manufacturing across US and UK facilities.
CuriRx, Inc.CuriRx, Inc. is a Wilmington, Massachusetts contract research and development organization. It offers formulation development, prefilled syringe and lyophilization services, bioprocessing, and analytical testing to pharmaceutical companies of all sizes.
CuriaGlobal CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.
Cytovance BiologicsU.S.-based CDMO offering end-to-end biomanufacturing services for antibodies, recombinant proteins, vaccines, and other biologics modalities, with dedicated microbial and mammalian facilities and in-house cell line development capabilities.
DipharmaGlobal CDMO and API manufacturer with 600 employees, 4 cGMP plants, and 75+ years of experience in hazardous chemical synthesis, offering exclusive synthesis services and catalogue APIs with FDA, AIFA, and PMDA inspections since 1970.
Divi's LaboratoriesWorld's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.
ElevateBioAdvanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale.
FUJIFILM BiotechnologiesCDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities.
FlammaPrivately held small molecule CDMO with FDA-inspected cGMP facilities in Italy, USA, and China, offering custom manufacturing, development, and specialized technologies including HPAPI, continuous flow, and cryogenic API synthesis from early-stage to commercial scale.
Forge BiologicsDedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance.
GBI BiomanufacturingFull-service biologics CDMO offering integrated development and manufacturing services including cell banking, upstream/downstream processing, bioconjugation, aseptic fill-finish, and regulatory support for complex biopharmaceuticals.
Gannet BiochemGannet BioChem is a specialized CDMO focused on activated polymer, PEG, and bioconjugation services for complex therapeutics, from early development through cGMP manufacturing. It operates facilities in Huntsville and Arab, Alabama.
GlattGlatt Pharmaceutical Services is a CDMO specializing in complex oral solid dosage forms, multiparticulate systems (pellets, micropellets, granules), and advanced drug delivery solutions including controlled release, solubility enhancement, and taste masking from early development through commercial manufacturing.
Global Biotech LaboratoriesGlobal Biotech Laboratories is a peptide and oligonucleotide CDMO offering end-to-end contract development and manufacturing from route scouting through validated commercial supply, with cGMP and ICH Q7 compliance across manufacturing sites on three continents.
Grand River Aseptic ManufacturingSterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.
Jubilant HollisterStierComprehensive sterile fill-finish and lyophilization CDMO with decades of experience, advanced automation, and white-glove service for global pharmaceutical partners.
KBI Biopharma, Inc.Global CDMO offering cell line development, process and analytical development, formulation development, and clinical and commercial manufacturing for mammalian and microbial biologics.
Kincell BioLeading cell therapy CDMO delivering GMP manufacturing, analytics, and CMC strategy from early development through commercial launch across purpose-built U.S. facilities.
Kindeva Drug DeliveryPurpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities.
Markdown mirror: /services/cmc-regulatory-support/us.md