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Reach Dx-cellence

With over 25 years experience, Eurogentec [part of Kaneka Corporation] is a leading supplier of highquality reagents for the Life Science Communities.

We offer a wide range of GMP oligonucleotide-based components and GMP Taq DNA polymerases for Molecular Diagnostic [Dx] applications, such as Molecular Diagnostic kits, Lab Developed tests [ASR] and companion Diagnostic.

Eurogentec’s Quality Management System (QMS) is fully compliant with the cGMP Quality System Regulation (QSR). We are also ISO 13485 certified for oligonucleotides synthesis and ISO 13485 compliant for production of Diamond Taq® DNA polymerases.

Our state-of-the-art cleanroom facilities meet Class 100,000 (ISO 8) and Class 10,000 (ISO 7) standards with Class 100 [ISO 5] working zones.

Broad Expertise

Over 25 Years in Oligonucleotide Synthesis
Over 18 Years GMP Experience
Complex Chemistry Expertise
Proprietary Dyes & Quenchers

Manufacturing Capabilities

From Small to Large Scale Oligonucleotide Production
GMP Taq DNA Polymerases
Highly Qualified Production Teams

Classified Cleanrooms

Controlled Key Card Access
Prevention of Cross Contamination
Controlled Environment

Regulatory Compliance

ISO 13485 Certified [Oligonucleotide Production]
ISO 13485 Compliant [GMP Taq DNA Polymerases Production]
Compliance to FDA cGMP/QSR [21 CFR Part 820]
EU IVD Directive 98/79 EC Compliance for QMS
Full Traceability

Supply Chain Reliability

Market Proximity
Back-up Solutions

Flexible Custom Solutions

Research, Pre-Diagnostic, Diagnostic Grades
Collaborative Project Development
Fill and Finish
Assay Set Assembly

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