Guiding you to global compliance
Regulatory Consulting
At CovarsaDx, our regulatory team brings unmatched expertise in guiding medical device and in vitro diagnostic (IVD) companies through the complex world of US FDA laws, regulations, and global regulatory compliance. Whether you’re navigating the 510(k), PMA, or De Novo pathway, we are here to ensure your product meets regulatory requirements while addressing risk management needs and the evolving regulatory environment to achieve efficient and successful outcomes.
Our regulatory team utilizes their relationships and experience with US FDA and other government agencies to collaborate closely with sponsors from design concept to market launch to develop and implement regulatory strategies that outline major development milestones, facilitating costs and timelines. Our team ensures that every aspect of product development aligns with FDA requirements and applicable standards, while providing guidance on the totality of data needed to demonstrate safety and effectiveness.
CovarsaDx’s regulatory experts work with sponsors to ensure that documentation effectively addresses FDA concerns while minimizing risk. They provide clients with accurate and timely service, supporting through every phase of the regulatory journey, from clinical trial design to post-market surveillance.

Strategic Regulatory Advisory

Reimbursement Strategy (Coverage Support and Policies)

Regulatory Pre-Submissions

Regulatory Submissions (510(k), IDE, PMA, De Novo, Breakthrough Device Designation)

Reports for PMAs, IDEs

FDA Meeting Preparation

Labeling Compliance

Pre-Clinical and Clinical Trial Protocols

Analytical Study Protocols

Biocompatibility Assessments and Strategy
Key Benefits of Our Regulatory Services:
- Proven track record of successful FDA submissions
- Comprehensive support from clinical trial design to post-market surveillance
- Expertise in navigating 510(k), De Novo, and PMA pathways
- Regulatory strategy tailored to your product and business needs