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)