Flexibility and Partnership are Key
Eurogentec understands the complex and oftentimes ambiguous EU and US statutes regulating the manufacture of assays and assay components destined for IVD applications. Additionally, Eurogentec has the practical knowledge and hands-on experience required to implement the numerous manufacturing & administrative systems needed for compliance.
Of course, our B2B Partners may have additional requirements that exceed our standard regulatory compliance systems. These may include requests for custom analytical, purification or QC protocols, expanded batch record documentation, custom-designed labelling and packaging and even plans identifying alternative manufacturing sites to guard against interruption of product supply stream. Based on input gained through regular partner consultations with our manufacturing management teams, we are able to provide our partners with custom-tailored plans that accommodate their unique compliance requirements.
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- Our management teams and production staff have the practical knowledge and expertise to customize most manufacturing processes to our partner’s specifications.
- Our main cGMP production site in Belgium is complemented with redundant production facilities in the U.S. and Japan.
- Our technical methods and processes are harmonized at each of our facilities ensuring each site’s adherence to Eurogentec’s technical, QC and Quality Management Systems.
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One Partner from R&D through Commercialization
Eurogentec recognizes that documentation requirements differ as IVD products progress from R&D and prototype phase to validation and eventual commercialization. Incurring no compromise in oligonucleotides quality, we offer our partners the flexibility of choosing from three increasingly detailed levels of documentation appropriate for each phase of product development:
1. RESEARCH Oligos
This is the most cost effective option. It is available for the early phases of assay development. Standard documentation provided.
2. Pre-DIAGNOSTIC Oligos
Attractively priced between Research and Diagnostic Oligos and tailored to the early phases of assay development. Provides oligonucleotides with the diagnostic process (diagnostic optimized and validated methods, qualified equipment) in a classified clean room facility. Controlled facility. Documentation is minimized to keep the cost down.
3. DIAGNOSTIC Oligos
Tailored for middle and late phases of product development and commercialization. Production and documentation are optimized for diagnostic purpose and can be fully customized according to our partner’s needs. Detailed checklists are used for all steps in the manufacturing process ensuring complete process control monitoring and traceability. This process is ISO13485-certified and fully GMP compliant (FDA 21 CFR part 820 QSR”)