Eurogentec offers cGMP custom manufacturing services for oligonucleotides that are part of IVD kits or lab-developed tests. Our cGMP production process and Quality Management System is compliant to ISO13485:2003 and FDA 21 CFR Part 820. EUROGENTEC is registered as an ASR manufacturer with the FDA under registration number 3003830126.
For details about our cGMP custom manufacturing services for diagnostic oligonucleotides, discover our Diagnostic pages.