Eurofins BioPharma Product Testing
Eurofins BioPharma Product Testing
As the largest international network of harmonized GMP 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 and LIMS to more than 2,000 pharmaceutical and biopharmaceutical 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 63,000 square meters and 22 facilities located in Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden and the U.S., our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. Further, we have teams of scientists placed at more than 60 client facilities throughout Europe and the U.S. through our award-winning Professional Scientific ServicesSM (PSS) insourcing program.
Experience Our Expertise
We offer complete CMC Testing Services for the Bio/Pharmaceutical industry, 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.
Collaboration Drives Cost-Effectiveness
Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs. As your project progresses to further enhance open dialogue and assist your decision making, we provide timely and secure access to comprehensive laboratory information through our innovative, 24-hour online data access tool, LabAccess.com.
Comprehensive Services
We offer the flexibility to manage your testing programs more efficiently through your choice of three unique service models, including our award-winning Professional Scientific Services (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals. Our breadth of services include:
- Method establishment, including method development, feasibility, optimization, cGMP qualification and validation, as well as verification of compendial methods
- Comprehensive stability and release programs for clinical and marketed products
- Complete biochemical and chemical characterization and microbial identification
- Raw material and excipient testing (USP/NF, EP, JP)
- Production and non-production cell banking including full characterization
- Lot release/unprocessed bulk testing
- Process/facilities validation, including viral clearance, residual impurities testing, extractables & leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection
- Consulting/protocol writing
Eurofins Assurance is Expanding its Quality Assurance and GxP Pharma Audit Offering With the Acquisition of Sisthema
+32 2 766 16 20
