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Combination Products
Tailor your co-development strategy for a streamlined path to market
KEY FIGURES
30+
Product development programs
10+
Therapeutic areas
100+
Master files
The Best of both Worlds
- Expertise in drugs, biologics, and devices
- Experience in identifying and leveraging incentives and opportunities for accelerated development
- At the forefront of breakthrough technologies and in direct contact with regulatory bodies, shaping the evolving regulatory framework
Comprehensive Product Expertise
We have hands-on experience covering a broad range of products such as drug delivery systems, photodynamic therapy products, sonodynamic therapy products, combined ATMPs, coated implantable devices, and scaffolds for grafts/implants for a wide range of applications.
FAQs
What is a combination product?
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biologics.
These can include products like drug-eluting stents, pre-filled syringes, and transdermal patches. Products may be combined via integral combination, co-packaging, or cross-labeling.
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How are combination products approved?
The approval process depends on the primary mode of action (PMoA) and type of combination.
If it is drug-led, the product is approved as a drug (MAA, NDA/BLA) and the device component will be evaluated by a notified body (CE-marking/NBOp) / FDA Center for Devices and Radiological Health (CDRH). Device-led products follow the device approval route (CE-marking, 510(k)/PMA), with the opinion on the ancillary drug component coming from the NCA/EMA and FDA CDER/CBER.
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Related Glossary
Combination product
Breakthrough Device Designation
In Vitro Diagnostic Medical Device (IVDMD)
Medical Device Software
SaMD / SiMD
Medical Device (MDR definition)
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.