Issuing Body Farmatec
Issuing Body Country NL - The Netherlands
Issuing Body Website https://eudragmdp.ema.europa.eu
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Eurofins BioPharma Product Testing Leiden BV operates as a GMP-certified laboratory with extensive experience in chemical, microbiological, and biosafety testing. We offer chemical QC testing, method development, validation and transfer studies, as well as stability and storage services. We are also highly specialised in process residuals and impurity testing, using proprietary in-house methods or customised method development. In addition to testing, we also have aseptic manufacturing units in which small-scale compounding and fill & finish activities of clinical trial and commercial material are performed. Furthermore, we offer related services, like labelling, packaging, storage, and GDP compliant distribution, as well as process and release testing services, and QP batch certification services. Microbiological and biosafety activities focus on microbiological quality control testing, biosafety testing, cell banking, and cell line characterisation, as well as the development and transfer of microbiological, viral, and cell-based assays. We are recognised as a Eurofins Centre of Excellence for mycoplasma testing, with many years of experience and the use of highly sensitive, in-house developed media covering a broad range of mycoplasma species. In addition to mycoplasma testing, a wide range of microbiological services is offered to support pharmaceutical development and manufacturing. We are certified in accordance with GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and have been accredited with ISO14001. Our teams of scientists and project managers partner with you throughout the outsourcing process from testing to monthly reports to 24-hour online data access at LabAccess.com. In close cooperation with our Eurofins BioPharma Product Testing network of laboratories across Europe, we offer a full-service package. Our local presence ensures personalised customer support for all analytical needs.
Issuing Body Farmatec
Issuing Body Country NL - The Netherlands
Issuing Body Website https://eudragmdp.ema.europa.eu
Issuing Body IGJ
Issuing Body Country NL - The Netherlands
Issuing Body Website https://eudragmdp.ema.europa.eu