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.
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:
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: