CMC Regulatory Submission Support CDMOs in Europe
49 published
49 published CDMOs match CMC Regulatory Submission Support in Europe.
Locations in this set include United States, United Kingdom, Germany, France, Switzerland, and China.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Peptide, and Antibody-Drug Conjugate (ADC).
Matching companies
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.
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.
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.
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.
MyBiotech GmbHGermany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products.
NuvisanFull-service CRO and CDMO with specialized competency centers in drug discovery, formulation development, GMP manufacturing, and bioanalytical services across Germany and France.
Oxford BiomedicaGlobal viral vector CDMO with 30 years of expertise in lentivirus, AAV, and adenovirus manufacturing. Provides end-to-end development and GMP-compliant manufacturing services from preclinical through commercial launch for cell and gene therapy programs.
PHT International, Inc.PHT International is a Contract Research, Development, and Manufacturing Organization (CRDMO) offering small-molecule process R&D, cGMP manufacturing from milligrams to multi-tons, and chemical sourcing with global facilities across North America, Europe, and Asia.
PI Health SciencesPI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.
PharmaBlockLeading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.
PharmaronPremier 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.
Piramal Pharma SolutionsCDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.
PolyPeptide GroupSpecialized global CDMO for peptide-based active pharmaceutical ingredients, supporting development and manufacturing of proprietary and generic APIs with expertise in peptide synthesis and GMP manufacturing.
Porton AdvancedEnd-to-end ATMP CDMO provider offering cell engineering, lentiviral vectors, mRNA/LNP, plasmid development, and GMP manufacturing from preclinical through commercialization with 24 IND approvals across NMPA, FDA, and MedSafe.
ProBioGen AGProBioGen AG is a CDMO offering cell line development, process development, GMP manufacturing and analytical services for proteins, antibodies, viral vectors and vaccines. It also provides technology platforms for biopharmaceutical manufacturing.
Quotient SciencesIntegrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.
Rotop Pharmaka GmbHROTOP Pharmaka GmbH is a Dresden-based radiopharmaceutical manufacturer offering end-to-end CDMO services for radiopharmaceuticals, from early-stage development to commercial supply.
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.
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