After product approval, there are usually various commitments toward the Health Authorities to guarantee continued safety and efficacy.

The RA team at 3D-PharmXchange can assist you with the strategy and execution of the post approval commitments you have obtained, regardless of whether they are clinical in nature or stem from the quality part of your dossier. Furthermore, we can also assist with risk minimizations measures such as risk managements plans and educational materials.

These commitments are related to protocol and report review and annual reports regarding the product’s performance. Our regulatory consultants can help you prep rate, write, review, and submit any of these outcomes and progress reports.

Get in touch
with our Xpert

Elise Destrée

Managing Consultant, Regulatory Affairs