Confidence Beyond Compliance
Before submitting a marketing authorisation application in the EU, there are a number of key processes to undertake which will influence the requirements and subsequent direction your new product takes. Most importantly, completion of these obligations will help ensure successful approval by the regulators.
Critical to the success of products are briefing documents submitted to the regulatory authorities. Our professional experts have extensive regulatory background to prepare a briefing document that will tell your product’s story. A well-written document advocates – on behalf of your team and your product – to address potential review issues as well as to get the agency to understand the potential benefits of your product. These documents need to be scaled to the right audience, containing relevant details and must be easily read and understood – we have the knowledge to prepare the right briefing book for the right audience.