Agency Interactions

The key to any successful regulatory strategy in Europe and the USA, or other geographical regions, is a fruitful interaction with the relevant regulatory agency. ERA is experienced in preparing for, and assisting clients at such meetings and hearings. This involves compiling a briefing document for consideration by the regulatory assessor in advance of the meeting. Such interactions should have clearly stated goals, and should contribute to agreement on the strategy to be adopted for the product, including the level of documentation required in the dossier.

Our team offers the following expertise:

We have had recent interactions with agencies in these areas:

ERA can provide a number of services in support of your agency meeting: