Eurofins BioPharma Product Testing Netherlands
COMPANY PROFILE
Description
Eurofins BioPharma Product Testing Netherlands is part of the Eurofins international network of harmonised product testing laboratories. With over 20 years of expertise, we serve the (bio)pharmaceutical and life sciences industries through our comprehensive testing, manufacturing, and consultancy services.
Our state-of-the-art laboratories offer a wide range of methodologies and are accredited under GMP, GLP, GDP, and ISO standards. Our services are fully comprehensive, and we are specialised in testing of pharmaceutical raw materials, intermediates, drug substances, and final drug products for both small and large molecule pharmaceutical products.
With extensive experience in developing test methods from scratch and transferring client methods under stringent regulatory conditions, we ensure high quality and compliance. Additionally, our multiple aseptic manufacturing units provide small-scale compounding, fill & finish activities, including labelling and packaging services.
By leveraging the extensive Eurofins network, we can offer a comprehensive service package for your products, ensuring full regulatory compliance. Partner with us to experience high-quality service and support in advancing your product development.
Eurofins BioPharma Product Testing Netherlands operates four laboratories located in the Netherlands covering a broad scope of testing services for pharmaceuticals.
Eurofins Bactimm B.V. (Nijmegen) is a microbiological contract laboratory with a focus on the pharmaceutical and medical device industry. This laboratory offers microbiological quality control testing for APIs, raw materials, finished products, and medical devices. Additionally, this laboratory is specialised in performing disinfectant studies, cleaning validations, and environmental monitoring services. Eurofins Bactimm B.V. also offers testing and consultancy services for medical devices, leveraging the broad Eurofins Medical Device Testing network of companies.
Accreditations: GMP (Human and Veterinary Medicinal products), ISO 14001:2015, ISO 9001:2015, ISO 13485:2016
Eurofins PROXY laboratories B.V. (Leiden, Bio Science Park) is a chemical testing laboratory focused on performing chemical quality control testing, chemical method development, validation, and transfer studies, and stability & storage. Eurofins PROXY laboratories B.V. is specialised in process residuals and impurity testing using proprietary in-house methods or custom-developed methods. Besides facilitating testing, there is also a manufacturing department where small-scale compounding and fill &finish activities can be performed. Labelling and packaging services and QP release for final products are also offered.
Accreditations: GMP (Human and Veterinary Medicinal products), GDP, ISO 14001:2015
Eurofins Microsafe Laboratories (Leiden, Bio Science Park) (part of Eurofins PROXY laboratories B.V.) is a microbiological contract laboratory specialised in microbiological quality control testing, cell banking, cell line characterisation, method development, and transfer of microbiological and viral assays in a GMP environment. Eurofins Microsafe Laboratories is a Eurofins Centre of Expertise in Mycoplasma testing with many years of experience in mycoplasma testing and in-house produced, highly sensitive, mycoplasma media for a broad range of mycoplasma. Next to mycoplasma testing, many additional biosafety testing services, such as virology testing, endotoxin testing, and testing using state-of-the-art molecular biology techniques, are offered.
Accreditations: GMP, ISO 14001:2015
Eurofins Spinnovation Analytical B.V. (Oss, Pivot Park) is a Eurofins Centre of Excellence for NMR spectroscopy. Eurofins Spinnovation Analytical B.V. is a chemical testing laboratory offering solid-state characterisation services, spent media analysis, NMR quality control testing, and root cause investigation services. For spent media analysis, we use our proprietary Spedia-Predict™ method, an innovative solution to evaluate performance variability and develop predictive models for specific bio Manufacturing processes. Additionally, solid-state NMR (ssNMR) characterisation services, such as reference qualifications, identification, and polymorphism, are offered all under GMP.
Accreditations: GMP, ISO 14001:2015
Contact Information
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