National activities

We have extensive experience with the German regulatory authorities

On the basis of our extensive experience with national procedures we can help you to optimise the application process and ensure that marketing authorisation is granted for your product as quickly as possible.

What we have to offer

• Strategic planning of your marketing authorisation projects
• Allowance for specific national factors
• Electronic processing in accordance with current requirements (eCTD, NeeS, AMG‑EV)
• Submission of dossiers
• Process management
• Ongoing support up to the point of marketing authorisation
• Interfacing with the competent regulatory authorities
• Comprehensive lifecycle management, e.g. variations, renewal applications, compliance, writing and submission of PSURs, etc.