Notified Body Opinion

Creating a documentation package for a notified body opinion can be a challenge for Pharma companies used to working within the drug development world.

New documentation requirements to combination products, driven by the introduction of the European MDR legislation, has made it necessary for Pharma companies to expand their documentation beyond the drug to cover the medical device as well.

The process of creating the required documentation for both when submitting for a notified body opinion is essential for Pharma companies to get in control of. With many years of regulatory affairs experience from projects in the life science industry, our specialists can help your organization bridge the gap between drug and device.