Regulatory Affairs

The Covita Health Partners Regulatory Affairs team is dedicated to championing disruptive life science technology to improve the health of patients around the globe. The team achieves this mission by providing expert regulatory support at any stage of the product lifecycle. With an unparalleled level of partnership, our team ensures that products reach the market swiftly while keeping you on budget and maintaining full regulatory compliance. We pride ourselves on being experts in leveraging the grey area of regulations and standards to develop unique and creative, but always compliant, regulatory strategies for our clients.

From initial strategy and submission to post-market surveillance and ongoing compliance management, we provide expert support to help you navigate the complex global regulatory landscapes efficiently. Our proactive approach not only accelerates market entry, but also safeguards long-term compliance to facilitate continued market access. This allows life science companies to focus on innovation while ensuring patient safety and regulatory adherence.

Expert Support from Start to Scale

Bringing a life sciences product to market is complex—and no two journeys are the same. That’s why we offer expert support at every stage of the product lifecycle, from early development through launch and beyond. Whether you're navigating initial regulatory planning, health authority interactions, regulatory submissions, commercialization, or post-market strategy, our team is ready to meet you where you are and help you move forward with confidence.

Ideation

Strategic Planning
Regulatory Strategy
Classification Determination

Development & Testing

Regulatory Authority Interactions and Meetings
Submission Planning
Designation Requests (BDD, STeP, RfD)

Marketing Submission

Submission/Technical File/Design Dossier Authoring, Review, Submission
OUS Device Registration

Commercialization

Registration & Listing
GUDID Support
Import/Export Support

Market Growth

Regulatory Assessment for Product Changes
Supplemental Applications
Advertising/Promotion Review
HHE

Multidisciplinary Expertise, Unified Impact

The CHP Regulatory Affairs team is built with industry professionals of diverse technical backgrounds which enable us to support an array of therapeutic areas, product types as well as global markets.

When you partner with us, you’ll not only benefit from working with individuals with the exact background your project requires, but also the experience and network of the entire team.

We have specific experience with nearly 50 therapeutic areas and indications, which we’re expanding nearly every day.

Our team has also supported medical devices in nearly every country and continent in the world. We can support the premarket review process in major markets such as the US, EU, UK and Canada. We can also support the OUS product registration process in countries in South America, Middle East and Africa, and Asia Pacific. Wherever your patients are, we can help you reach them with our breadth of experience and reach of our network.

>500

The combined numbers of 510(k), De Novo, PMA, IDE, HUD, BDD, Q-Sub, CE Mark and MDL submissions our team has made

The number of NSE or denial responses our team has received

With our proprietary Q-Sub strategy for seeking FDA feedback, we also have a nearly perfect record in facilitating the feedback our clients desire on their regulatory and development plan.