SERVICES
Exceeding Your Expectations
Regulatory Affairs
Our seasoned Regulatory Affairs consulting team has a deep expertise and passion for helping life science companies of all sizes around the world at each stage of the product lifecycle. From product ideation strategic planning, to post-market compliance planning, execution and maintenance, our team is in lock-step with you to ensure your goals are met. We stay current with industry innovation and the ever-changing global regulatory environment so you don't have to.
Premarket Notification 510(k)
Our team is knowledgeable and experienced in navigating the FDA’s cumbersome pre-market approval process. We have pushed hundreds of 510(k) submissions through the process and can quickly guide your organization to success.
Quality Assurance
Our seasoned Quality Assurance consulting team has a deep expertise and passion for helping life science companies of all lifecycles through the aspects of quality and efficiency.
Capabilities
OnemataDC's team supports our clients with regulatory and quality efforts surrounding Medical Devices, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and Combination Products globally.