Combination Products
Our MedTech and Clinical Operations Experts Work Closely to Maximize the Potential of a Device/Drug Combination Product – Ensuring a Pathway for Regulatory Approval
The Best of Both Worlds
Device Consulting Expertise Meets Clinical Development Excellence
Combining a device and drug can benefit patients by delivering more targeted treatment options, improved drug delivery mechanisms, and enhanced efficacy. While there is a universal need for combination products, regulations are highly variable by country.
Our knowledge of local device regulations, therapeutic expertise, and global clinical operations capabilities enable scalable solutions for all program types and across medical device categories.
We know what to ask up front:
- When should you first engage with regulators?
- What agency divisions do you need to engage with?
- How can you best prepare sites for study execution?
- What about pricing, and ensuring that your device will qualify for separate reimbursement?
Contact Premier today for strategic support with your development program.
Agility and knowledge at your fingertips
Resources
Perspectives Blogs
UPDATE – Draft FDA Guidance Concerning Combination Products
As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019.
Perspectives Blogs
Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%.
