Combination Products

Combination products fail when drug product, device engineering, CMC, clinical and quality teams work in isolation. We assist sponsors developing a single integrated regulatory and quality storyline by providing primary mode of action, RFD strategy, 21 CFR part 4 compliance with design controls, human factors, risk management, supplier controls, documentation of device constituents, and submission alignment from IND through NDA/BLA lifecycle.

We support drug-device, biologic-device, prefilled syringe, autoinjector, on-body injector, inhalation, transdermal and co-packaged product programs where FDA expectations cross CDER, CBER and CDRH boundaries.