New service streamlines regulatory strategy, submission support, and compliance for point-of-use diagnostic devices
SAN DIEGO, March 13, 2025 /PRNewswire/ — DCN Dx, specializing in IVD CDMO and CRO services, has launched Regulatory Affairs Services, a new solution designed to help clients navigate complex regulatory pathways efficiently and successfully. The new offering provides comprehensive support for FDA and international regulatory approvals, ensuring diagnostic developers can bring their innovations to market faster and with confidence.
With expertise in regulatory strategy, pre-submission consultation, accelerated review pathways, and compliance, DCN Dx’s full-service regulatory solution is tailored to the unique needs of in vitro diagnostic (IVD) developers and manufacturers. This expansion complements the company’s established assay development, product design, and commercialization services, reinforcing DCN Dx as a single-source partner for diagnostic device development.
“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, DCN Dx CEO. “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.”
DCN Dx’s Regulatory Affairs Services include:
- Regulatory Strategy Development: Tailored roadmaps for FDA (510k, De Novo, PMA), IVDR/MDR compliance, and global regulatory pathways.
- Pre-Submission & Regulatory Consultation: Guidance on FDA interactions, pre-submission meetings, and regulatory risk assessment.
- Accelerated FDA Review Pathways: Support for Breakthrough Device (BTD) and Safer Technologies (STeP) programs to expedite approval.
- Regulatory Submissions: Assistance with IDE, 510(k), De Novo, PMA, and international filings.
- Additional Compliance Services: QMS audits, post-market surveillance, and regulatory gap assessments.
With this launch, DCN Dx strengthens its commitment to comprehensive diagnostic development support, helping clients efficiently navigate regulatory requirements and achieve market clearance with confidence.
For more information, visit dcndx.com.
About DCN Dx
DCN Dx, based in Carlsbad, California, specializes in lateral flow diagnostics development and manufacturing, and IVD regulatory consulting and clinical research. DCN Dx’s multidisciplinary CDMO specializes in creating tailored assay systems, consumables, and instruments for point-of-use applications, with a particular expertise in lateral flow assays. Their clinical research services group specializes in the planning, execution, and oversight of IVD clinical trials, inclusive of clinical operations, data management, and biostatistics, and regulatory services.
With a commitment to quality, customer satisfaction, and industry-leading expertise, DCN Dx is setting the benchmark for excellence in IVD services. To learn more about how we can support your diagnostic needs, visit dcndx.com.
For more information contact:
Mitzi Rettinger
Chief Revenue Officer, DCN Dx
Main: (760) 804-3886
Mobile: (512) 431-5836
391769@email4pr.com
SOURCE DCN Dx
