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
Overview
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?
Integrations
Industry leaders with comprehensive submission experience position your product strategically
Managing & delivering every study with your business priorities in mind
Integrated, technology-enabled approach to drive efficiency and quality across clinical development
Optimize with a science-driven, patient-centered approach to clinical research
Insights
Agility and knowledge at your fingertips
UPDATE – Draft FDA Guidance Concerning Combination Products
Early Regulatory Insights
resources
Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.
Ready to get started? So are we.
Drop us a line to learn more about how we can help.