Certification
EMA-Certified CDMOs
Compare CDMOs with EMA GMP certification for EU-market pharmaceutical manufacturing. Filter by product type, member state, and manufacturing capabilities.
349 companies listed
About EMA GMP Certification
EMA (European Medicines Agency) GMP certification confirms that a manufacturing facility complies with EU Good Manufacturing Practice standards. GMP inspections are conducted by national competent authorities (e.g., BfArM in Germany, ANSM in France, MHRA in the UK) and the resulting GMP certificates are recognized across the EU through mutual recognition.
The EMA maintains Mutual Recognition Agreements with regulatory agencies in the US, Canada, Australia, Japan, Switzerland, and other countries. This means EU GMP inspections may be accepted by these agencies without re-inspection, reducing the regulatory burden on CDMOs serving multiple markets. The Qualified Person (QP) system -- unique to the EU -- provides an additional layer of batch release oversight.
Companies (349)
Quotient Sciences
United Kingdom
Quotient Sciences is a UK-headquartered pharmaceutical CRDMO (contract research, development, and manufacturing organization) specializing in small molecule and synthetic peptide drug product development and manufacturing. They offer integrated formulation development, clinical manufacturing, and commercial production, with their proprietary Translational Pharmaceutics approach integrating clinical activities with real-time cGMP manufacturing. They have facilities in the US and UK, with capabilities including HPAPI manufacturing, sterile fill/finish, and oral solid dose.
Small Molecule Drug ProductOral Solid DoseFormulation Development
RD‑Biotech
France
RD-Biotech is a French biotechnology CRO/CDMO founded in 2002, offering custom solutions in molecular biology, immunology, and cellular engineering for R&D, preclinical, and clinical programs. They specialize in plasmid DNA production (including GMP grade), monoclonal antibodies, recombinant antibodies, recombinant proteins, and cell culture/banking. They have a strategic partnership with ABL for cell and gene therapy GMP manufacturing.
Frequently Asked Questions
How does EU GMP certification work?+
National competent authorities in EU member states conduct GMP inspections of manufacturing facilities. If compliant, the authority issues a GMP certificate valid for up to 3 years. The certificate covers specific activities (manufacturing, testing, batch release) and product types. The EudraGMDP database is the public registry of EU GMP certificates -- you can verify any CDMO's current certification status there.
What is the Qualified Person (QP) role?+
The Qualified Person is a unique EU regulatory requirement. Every batch of pharmaceutical product released in the EU must be certified by a QP -- a named individual with specific academic qualifications and experience. The QP takes personal legal responsibility for confirming that each batch was manufactured and tested according to GMP requirements and the marketing authorization. CDMOs serving the EU market must have access to QP services.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
