- DCN Dx has launched Regulatory Affairs Services to assist clients in navigating FDA and international regulatory pathways.
- The service includes support for regulatory strategy, pre-submission consultation, compliance, and accelerated FDA review pathways.
DCN Dx has introduced Regulatory Affairs Services, a new solution aimed at helping in vitro diagnostic (IVD) developers and manufacturers efficiently navigate complex regulatory approval processes. The new offering provides comprehensive support for FDA submissions and international regulatory compliance, enabling clients to bring their diagnostic innovations to market with greater confidence.
The service includes expertise in regulatory strategy development, pre-submission consultation, compliance assessments, and support for accelerated review pathways. It is designed to streamline approvals for various regulatory frameworks, including FDA’s 510(k), De Novo, and PMA processes, as well as international standards such as IVDR/MDR compliance.
“Bringing a diagnostic device to market requires more than technical innovation. It demands a clear regulatory strategy and a deep understanding of compliance requirements,” said Charlie Mamrak, CEO of DCN Dx. “Our new regulatory affairs services eliminate uncertainty in the approval process, helping our clients achieve market clearance efficiently while maintaining the highest standards of quality and compliance.”
The new service complements DCN Dx’s existing offerings in assay development, product design, and commercialization, reinforcing its position as a single-source partner for diagnostic device development. Clients will benefit from tailored regulatory roadmaps, pre-submission guidance, regulatory risk assessments, and post-market compliance services.
With this expansion, DCN Dx strengthens its commitment to providing end-to-end support for diagnostic developers, ensuring a seamless pathway from product conception to regulatory approval and market launch.
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