Diagnostic cGMP Oligonucleotides

With over 20 years experience in custom oligonucleotide synthesis, Eurogentec is as a leading supplier of high quality reagents for genomic research to bench scientists around the globe.

With the recent expansion of our state-of-the-art GMP (Good Manufacturing Practice) facility and our ISO 13485 certification for production and sales of IVD oligonucleotides in Liège, Belgium, we have significantly increased our capacity for manufacturing cGMP components for DNA- and RNA-based Molecular Diagnostic assays.

Together with our manufacturing facilities in the United States and Japan, we offer global redundancy and harmonization of experience, processes and facilities to ensure to our clients an uninterrupted supply of high quality R&D and GMP-level assay components.

Choosing a manufacturing partner early in an assay development process is an important first step toward successful assay validation and product commercialization.

Eurogentec has extensive experience in all aspects of GMP manufacturing: from synthesis and purification to exhaustive FDA and CE quality compliance for fully customized filling, labelling and packaging. Our QA staff is very knowledgeable of European and U.S. regulatory guidelines and standards, ensuring strict adherence to the demands of regulatory oversight. Our facility and processes are fully compliant with European IVD directive 98/79 EEC and U.S. FDA regulations for GMP (FDA 21 CFR Part 820 QSR/cGMP) and Analyte Specific Reagents (21 CFR Part 820, 21 CFR 809.10, 809.30, 864.4020).