Marketing Authorization Applications

Services

From development to market

After years of research and development it all comes down to filing the marketing authorization application. 
The MAA procedures are complex and additional Regulatory requirements are needed for biotechnology-derived products, ATMPs or GMOs.
Without considered planning and adequate experience one will finally end up in troubled water. 
With years of experience I will guide you through the exhausting licensing procedure and it will be worth it.

My services include

 
MAA Procedure
  • Strategic planning
  • EU-compliant CTD dossiers preparation and compilation
  • Coordination of the MAA procedure (CP, MRP/DCP or national)
  • Communication with health authorities on behalf of the applicant

Pre-Submission Activities
  • Pre-submission meetings and scientific advice meetings: document preparation and coordination
  • Product information preparation
  • Submissions of eligibility