CMC Regulatory Submission Support CDMOs
119 published
119 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
BioVectraNorth American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.
BioconFully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.
Biomay AGGMP CDMO specializing in plasmid DNA, mRNA, and recombinant protein manufacturing from gene construction to market supply, with in-house mRNA lipid-nanoparticle formulation and aseptic fill-finish capabilities.
BiospringGlobal CDMO leader in nucleic acid manufacturing and analysis (mRNA, ASO, siRNA, guide RNA, oligonucleotides) with nearly three decades of expertise, GMP certification since 2007, and support for 9 commercial programs across all clinical phases.
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.- Burrard PharmaceuticalsVancouver-based CDMO delivering technology transfer, formulation development, and GMP manufacturing for 75+ molecules across oncology, diabetes, and respiratory therapeutics since 2005.
CDMO NetworkCDMO Network is a biomanufacturing partner-routing platform that connects biotech sponsors with specialized CDMO partners across modalities, development stages, and geographies to reduce integration friction and accelerate program execution.
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.
CPC ScientificCPC Scientific provides GMP peptide and oligonucleotide manufacturing for Phase I through commercial programs, plus custom synthesis and FTE services for research applications.- 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.
Carbogen AmcisFull-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.
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.
Cell TherapiesGMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific.
Cell and Gene Therapy CatapultUK-based innovation and manufacturing support organization for cell and gene therapies, offering infrastructure, expertise, and collaboration across the ATMP lifecycle.
Cellab CDMOCell and gene therapy CDMO providing cell banking, GMP manufacturing, cryopreservation and EU QP batch release for clinical-stage ATMPs. Operates a 1,000 m² facility with four Grade B and one Grade C cleanroom plus an AABB-accredited cell bank.
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.
CelonicSwiss-based pure-play biologics CDMO specializing in next-generation bioprocessing technologies including process intensification and full perfusion to reduce cost of goods for biotech and biosimilar clients.
CelularityCelularity is a clinical and commercial-stage biotechnology company specializing in off-the-shelf placental-derived allogeneic cell therapies and advanced biomaterial products.
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.
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