Organisation of authority contacts

Meetings with regulatory authorities are business critical. They provide you with the current thinking of regulators and help you put things on the right track at essential junctures on your development pathway. They also create value e.g. for your investors and by generating the awareness of future regulatory decision makers. In order to maximise the benefit of such meetings they must be well planned and organised.

We support you in:

• Generating the contact strategy, by defining the appropriate time point of interaction, analysing the issues to be addressed and selecting the most suitable authority with whom to clarify your questions.
• Setting up the meetings and preparing the authority briefing documents.
• Facilitating your meetings, writing the meeting minutes and integrating the particular results into your development plans.

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development