Combination products are devices containing active pharmaceutical ingredients (APIs), which they deliver into the body. Combination products are defined more widely in 21 CFR 3.2(e) as “therapeutic and diagnostic products comprising two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.“
These drug delivery devices are designed for, and adapted to, specific routes of administration; skin (and mucosal membrane) patches for subcutaneous delivery, inhalers for airway delivery, syringes, injectors and pumps for intravascular delivery, and implants for long-term administration. All require Design Validation Testing for safety and efficacy.
MET’s non clinical CRO laboratories are staffed by knowledgeable scientists who are equipped to provide all aspects of non-clinical testing: chemical interactions, dose accuracy, human factors, physical performance, toxicity, stability sub-visible particle analysis, and much more.
For generic drug manufacturers, we can deliver a complete Reference Listed Drug (RLD) predicate comparison. This includes all aspects of device performance, API concentration and in-vitro bioavailability.
Our experience includes sustained release products, injection devices, oral delivery systems and transdermal items.
The types of combination device we assess include:
- Auto injectors
- Bone grafts and implants
- Muscular implants
- ‘On body’ pumps and delivery systems
- Pre-filled syringes, pen injectors, cartridges, and pump reservoirs
- Sustained release creams and ointments
- Syringe and peristaltic pumps
- Transdermal patches
- Vaginal rings
The laboratory team at MET is ready to help with complex projects or provide support on individual tests. We even have design validation plans available on request for many of these devices.
Contact us about your project now.