CDMOs offering CMC Regulatory Submission Support with Biologics (Other) in United States
22 matching organizations
CMC Regulatory Submission Support with Biologics (Other) in United States is a frequent shortlist pattern for sponsors evaluating CDMO partners with regional footprint. This page lists organizations that map to all three dimensions so you can move from broad taxonomy browsing to a geography-aware candidate set.
Profiles emphasize fit-first discovery: review scope, regulatory posture, and provenance on each listing rather than treating this page as a single ranked recommendation.
When you need additional filters (indications, claim status, or free-text search), continue to the main search experience and layer criteria on top of this starting point.
Directory listings on this page are fit-first and provenance-backed; sponsors are labeled separately and do not alter organic ordering.
- AGC Biologics
Global 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.
- Abzena
Fully 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.
- Almac Group
Global 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.
- Ardena
Ardena 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 Solutions
Ascendia 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.
- BSP Pharmaceuticals
BSP 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.
- Catalent
Global 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.
- Charles River Laboratories
Charles 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.
- Curia
Global 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 Biologics
U.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.
- FUJIFILM Biotechnologies
CDMO 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.
- Grand River Aseptic Manufacturing
Sterile 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.
- 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.
- Lifecore
Lifecore 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.
- Northway Biotech
End-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.
- 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.
- Pharmaron
Premier 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.
- Pyramid Pharma Services
US-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.
- Samsung Biologics
Leading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
- Simtra BioPharma Solutions
Simtra BioPharma Solutions is a CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and bioconjugation services for clinical and commercial products.
- Syngene International
Innovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
- Vetter Pharma
Independent CDMO specialist in aseptic fill-finish, drug product development, analytical services, and combination product assembly with 76 years of experience and 7,300+ employees globally.
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