Regulatory Agency Meetings

Guidelines can sometimes be unclear for your product and gaining insight into the Regulatory Agencies thinking on the testing, appropriateness of studies etc can provide valuable information and determine the best path forward saving time and money.

Within the EU, companies can ask the regulators questions at any point prior to the marketing authorisation application – the advice is an opportunity to optimise the regulatory pathway by asking the right questions – they will not be providing an opinion on the data generated to date.

Peritus Regulatory support:

• Manage meeting logistics with regulators, prepare briefing books, co-ordinate communications and note minutes.

• Help identify the technical questions for discussion.