Eurofins Alphora provides API technology development services for complex niche small molecules, covering pre-clinical to Phase III and commercial manufacturing. Alphora operates FDA-approved facilities totalling 51,000+ ft² including cGMP Kilo Laboratories and cGMP Plant operations, R&D and Analytical laboratories, QC/QA, as well as a separate high potency/cytotoxic facility.
Eurofins Amatsigroup is a leading international Contract Development and Manufacturing Organization (CDMO), headquartered in France. Within Amatsigroup, we provide high-quality, customized and cost-effective drug development solutions, integrated under one roof, to small biotech and major (bio) pharmaceutical customers. Our innovative and flexible approach enables customers to speed up their drug development process, achieving key milestones in a timely manner. The company has three strategic pillars:
- Drug substance process development and manufacturing for biologics,
- Pharmaceutical analysis solutions: fit-for-purpose method developments and validations, stability studies and Quality Control (QC)
- Formulation development and manufacturing of sterile and non-sterile clinical or small commercial batches.
Global BioPharma Product Testing within your reach As the largest international network of harmonized GMP and GLP product testing labs, Eurofins BioPharma Product Testing delivers a true local service experience. Eurofins BioPharma Product Testing offers the most complete range of testing services, harmonized quality systems to more than 800 virtual and large pharmaceutical, biopharmaceutical and medical device companies worldwide. In Our World, Global Is Local Our local presence ensures personal service backed by a unique global breadth of harmonized capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation and quality control. With a global capacity of more than 92,000 square meters and facilities located in Australia, Belgium, Canada, Denmark, France, Germany, India, Ireland, Italy, Spain, Sweden, Switzerland, Netherlands, New Zealand, UK and the US, our network of GMP laboratories operates under the same strict quality procedures, LIMS and centralized billing system across 28 locations worldwide. Further, we have teams of scientists placed at more than 44 client facilities throughout Europe and the U.S. through our award-winning Professional Scientific Services (PSS) insourcing program. Experience Our Expertise We offer complete manufacturing control testing services for the pharma and biopharma industries, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology. International Presence Means Global Regulatory Compliance Operating under the same strict quality procedures, our laboratories offer a broad range of methodologies under GMP authorization, ISO 17025 accreditation and ISO 9000 certification, and all analysis are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP) and Japanese Pharmacopeia (JP), as well as specific customer methods. Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.