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GMP products for molecular diagnostics

Products for in vitro diagnostics (IVDs) and laboratory-developed tests

Our GMP services place an emphasis on making you and your requirements the top priority while also demonstrating an expertise and commitment to enabling discoveries in biology and medicine. When you work with our team, a single dedicated account advocate will provide you with personalized and consistent management of your GMP experience, from project feasibility through commercial or clinical production. We ensure that your products are made to your exact specifications while adhering to your requirements at every step.

  • Easily transition from RUO to IVD by aligning specifications and methods from research to GMP
  • Receive a full range of OEM services, including customized formulation, labeling, and packaging
  • Obtain license-free fluorophores, including fluorescein, Cy®, rhodamine, and ATTO™ dyes

MGB Eclipse® Probes »

MGB probes manufactured under GMP conditions for use in human IVD applications. Order with companion GMP primers and select from a variety of fluorophores with no licensing restrictions.

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GMP probes and primers »

DNA oligos manufactured under GMP conditions and suitable for use in clinical diagnostics. Import multiple sequences from an Excel or text file and select from a wide range of modifications.

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Manufacturing process and traceability

When you order products manufactured under GMP conditions from IDT, you receive the highest standards of traceability. When working with our GMP team, you can define and monitor all aspects of the manufacturing process of your product. As a GMP customer, you will have access to:

  • World-class LIMS batch records for every order
  • Hard-copy analytical QC documentation for every product
  • Long-term quality agreements and contracts to ensure a stable supply of high quality GMP oligos

Legal and regulatory guidance

A quality GMP team should help you manage the regulatory and legal burdens that exist in the diagnostics space. Our facilities are ISO 13485:2003 certified and compliant with US FDA Quality System Regulation 21 CFR, Part 820. We maintain an “open door” audit policy.

Our common regulatory solutions include:

  • On-site product or process audits with our Quality Assurance team
  • Validation programs for all equipment and processes
  • A rigorous product-release process managed by our Order Verification and Release team

Our team of experts is ready to help you take the next steps as you transition from research to clinical and molecular diagnostics. Contact us to schedule your free consultation.

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