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
SEQENSGlobal CDMO and specialty ingredients manufacturer with 16 production sites and 9 R&D centres offering custom development and GMP manufacturing of pharmaceutical APIs, intermediates, and specialty chemicals from preclinical to commercial scale.
SK pharmtecoSK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.- STC BiologicsBoutique biologics CDMO with a Speed-to-Clinic platform spanning royalty-free cell line development through cGMP drug substance, in as little as 12 months. Runs a single-use mammalian GMP suite in Newton, MA for antibody, bispecific, and ADC programs.
Sai Life SciencesIntegrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients.
Samsung BiologicsLeading 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.
SannerMedical device CDMO offering design, engineering development, clinical and commercial manufacturing, plus 60+ years of expertise in desiccant primary packaging for moisture-sensitive pharmaceuticals.
Scinai Immunotherapeutics Ltd.Boutique biologics CDMO providing analytical method development, process development, and cGMP manufacturing for biotech clients from early research through Phase 3, backed by over 20 years of experience and state-of-the-art facilities.
Siegfried HoldingGlobal CDMO with 16 production sites across four continents, offering integrated development and manufacturing from early-phase to commercial scale for drug substance and drug product.
Simtra BioPharma SolutionsSimtra 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.
Sinopep-Allsino Biopharmaceutical Co., Ltd.GMP peptide and oligonucleotide CDMO offering custom synthesis, NCE development, CMC manufacturing, and finished dosage form formulation services for therapeutic programs.- Sky PharmaSky Pharma is a pharmaceutical supply partner offering custom manufacturing, API sourcing, excipient procurement, and finished dosage form distribution with integrated quality, regulatory, and cold-chain logistics support.
Sophia CDMOEuropean CDMO specializing in microbial and precision fermentation up to 40,000 L across two integrated sites (Pamplona, Spain and Basel, Switzerland), with core strengths in E. coli expression, animal health biologics, probiotics, and complex CMC programs requiring scale-up discipline and impurity control.
Sterling Pharma SolutionsSmall molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation.
Syngene InternationalInnovation-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.
SynthegoSynthego manufactures GMP-grade CRISPR components and molecular biology reagents for clinical and research applications, with 19 INDs cleared and 200+ clinical sgRNA batches produced.
Unither PharmaceuticalsGlobal CDMO specializing in sterile and non-sterile liquid manufacturing, including Blow-Fill-Seal (BFS) single-dose technology with over 5 billion annual capacity, plus formulation development, analytical services, and ophthalmic expertise across six production sites.
Vetter PharmaIndependent 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.
Wheeler BioOklahoma-based CDMO specializing in antibody-based therapeutics from cell line development through cGMP manufacturing. Offers ModularCMC platform with phase-appropriate work packages and high-touch project management.
Winkem Labs Pvt. Ltd.Contract development and manufacturing organization (CDMO) offering complex chemical synthesis, process development, API manufacturing, and supply services for pharmaceutical clients globally.
WuXi BiologicsGlobal biologic CDMO offering end-to-end solutions from discovery to commercialization.
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