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
Grifols PartnershipCDMO specializing in small molecule injectable products, including concentrated and diluted parenteral formulations and intravenous solutions, leveraging 100+ years of Grifols expertise.
HalixHALIX is a mammalian expression CDMO specializing in viral vectors, viral vector vaccines, and recombinant proteins from development through GMP manufacturing and fill-finish at clinical and commercial scale.- HillgeneHillgene is a leading CDMO provider specializing in cell therapy manufacturing, offering end-to-end solutions for CAR-T, TCR-T, CAR-NK, and UCAR-T cell therapies with GMP facilities in Suzhou and Belgium.
Hongene Biotech CorporationHongene is a vertically-integrated CDMO offering end-to-end oligonucleotide and mRNA manufacturing from raw materials to GMP drug product, with nearly 30 years of RNA-focused expertise and tonne-scale production capacity.
IDT AustraliaIDT Australia is a cGMP CDMO delivering end-to-end pharmaceutical development and manufacturing services from active pharmaceutical ingredients to finished dosage forms, with expertise in small molecule APIs, specialty orals, advanced therapies, and integrated regulatory support.
JYMed PeptidePeptide CDMO offering custom synthesis from milligrams to metric tons, with 13 cGMP lines and FDA-, NMPA- and EDQM-approved sites. Provides peptide API manufacturing plus syringe, cartridge and lyophilized finished-dose filling at its Shenzhen site.
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.
LGM PharmaLGM Pharma offers full-service CDMO support from concept through commercialization, plus API sourcing. It provides analytical method development and stability testing for APIs and drug products, with regulatory strategy support for 505(b)(2) and ANDA filings.- Laurus LabsGlobal pharmaceutical company specializing in APIs, formulations, and CDMO services for small molecule and biologics.
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.
Lupin LimitedGlobal pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.
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.
MyBiotech GmbHGermany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products.
Neuland LaboratoriesGlobal API CDMO supporting biotechnology and pharmaceutical companies in design, development, and manufacturing of complex active pharmaceutical ingredients from early-stage drug development through commercial scale.
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.
NuvisanFull-service CRO and CDMO with specialized competency centers in drug discovery, formulation development, GMP manufacturing, and bioanalytical services across Germany and France.
OmniabioOmniaBio is a cell and gene therapy CDMO specializing in process development, analytical development, and GMP manufacturing for lentiviral vectors, iPSCs, and immune cell-based therapies. The company operates a 120,000 sq ft facility in Hamilton, Ontario, integrating AI, automation, and robotics to deliver scalable manufacturing from preclinical to commercial stages.
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