Strategy & Requirements

We can provide continued or one-off support with the following regulatory activities in EU, US and RoW for innovative or generic medicinal products:

  • Advice on and/or creation of Regulatory Strategy (global/specific markets)
  • Advice on regulatory environment and requirements for specific markets
  • Advice on selection of regulatory procedure, application type, legal basis and related activities
  • Preparation of regulatory submission plan and risk mitigation strategy, identifying key activities, milestones and major regulatory challenges
  • Organisation and planning of pre-submission activities, including but not limited to pre-submission meetings, submission slots and preparation of documents, including but not limited to meeting requests, letters of intent, briefing packages, etc.
  • Support in the planning and organisation of authority meetings
  • Liaison with Competent Authorities on behalf of the MAH
  • Ongoing support to manage and execute the required regulatory activities as outlined in proposed strategy and submission plans