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QSR (cGMP Compliant) Manufacturing
TriLink's QSR Environment

In the challenging field of molecular diagnostics, quality and reproducibility are essential. TriLink is committed to providing the highest quality nucleic acid compounds for your diagnostic and therapeutic needs. Our research reagents and technical support are unsurpassed.

TriLink will work with you to develop, document and validate processes and materials for your specific product needs. We will then manufacture your product in our special suite of laboratories dedicated to production under a quality system based on QSR and the ISO 1345 standard.

Benefits of Manufacturing under QSR:
    • Multi-gram batches
    • Lot to lot consistency
    • Optimized purification protocols
    • Ultra-filtration desalting available
Products Offered:
QSR Manufacturing Program Guidelines Include:
    • All personnel trained in QSR compliant protocols           
    • SOPs and central records handling
    • Complaint handling program
    • Supplier validation and raw material handling
    • Controlled access to dedicated laboratories
    • All production processes include:
      Traceable batch records
      Calibration and maintenance programs
      Product segregation procedures
    • Independent QC verification
    • Complete confidentiality assured

Please contact us to discuss your QSR manufacturing needs.
Toll Free: (800) 863-6801
Email: info@trilinkbiotech.com

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