Combination Products (List) | Covita Health Partne

Combination Products

As life science innovation continues to evolve and progress, more products that combine a drug or a biologic with a medical device are emerging. The combination of these two product types into one product also combines the applicable regulatory and quality requirements, which adds even greater complexity to already complex products and development pathway.

Covita Health Partners understands these challenges. By keeping patients and compliance at top of mind and leveraging our vast resources and experience, network, and innate creativity, we can help get you where you want to go, when you want to get there. Our team has supported many combination products, both device-led and drug/biologic-led. We have a deep understanding of the medical device and combination product lifecycles and the distinct challenges at each phase. CHP is uniquely positioned to help you navigate these complex issues to stay on budget, stay on the right side of compliance, and accelerate product development and commercialization.

Click on the phases of the combination product lifecycle below to learn more about how we can partner with you at each phase.

Ideation

In the concept phase of a combination product, aligning the drug, device, or biologic components with regulatory and quality strategy is essential to set a clear path for development.

Development and Testing

During the development and testing phase, combination products undergo integrated design, verification, and validation to ensure safety, performance, and regulatory compliance of all constituent parts.

Marketing Submission

The premarket submission phase involves preparing and submitting comprehensive data to regulatory authorities, demonstrating the combination product’s safety, effectiveness, and compliance with applicable requirements.

Commercialization

In the commercialization phase, the combination product is launched to market with continued regulatory oversight, requiring coordinated quality, supply chain, and postmarket strategies to ensure ongoing compliance and product success.

Market Growth

During the market growth stage, focus shifts to scaling production, expanding market access, and optimizing postmarket surveillance to support broader adoption while maintaining regulatory compliance.