Marketing Authorisation Applications

We can help you in your European Marketing Authorisation Applications by offering a full range of services. We customise our support to your company’s and products needs from full project management to an extra pair of hands.

  • Advice on legal basis and optimal choice of regulatory procedure (CP, DCP, MRP)
  • Arranging and/or accompanying clients to pre-submission meetings with EMA and National Agencies
  • MAA writing (Modules 1, 2 and 3), compilation, publishing and submission for Centralised/DCP/MRP/national procedures
  • Management and coordination of regulatory procedures
  • Responses to questions (strategy and writing)
  • SPC, leaflet and labelling (writing, review of competitor labelling, coordination of translations)

Interested in our service? Let's talk

“This is to let you know that the team in France did a very good job in updating the Product Information.  Thank you in advance for your continuous professional support.”

Senior Regulatory Affairs Director, EMEA for a SME company