Health Authority and Notified Body Meetings

Sharp Regulatory are experienced with many different types of meetings with Notified Bodies and health authorities around the globe.

Such meetings allow a regulatory authority to provide their insights on the appropriate studies, testing and pharmaceutics to be considered during asset development.  Their feedback often provides clarity on the expectations for marketing development, although it must be remembered that any advice is prospective in nature and focusses on strategy, it is not an opportunity to obtain a pre-evaluation of data.

Sharp Regulatory can help with all aspects of meetings including arranging meetings, formulating questions, writing briefing books and provision of meeting minutes.