Oligos for in vitro diagnostics (IVDs), analyte-specific reagents (ASRs), next generation sequencing (NGS), 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.
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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.
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.
When you order oligos manufactured under GMP conditions from IDT, you receive the highest standards of traceability. The controlled and validated process is governed by the Oligo Master Record (OMR)—our collaborative playbook for how we produce your oligos every time you order.
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:
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:
You can obtain our industry-leading synthesis technologies, manufacturing capabilities, and technical expertise as a comprehensive third-party OEM service. Have custom-formulated products with your own labels and packaging shipped directly to your customers.