Full regulatory support: from initial guidance to dossier preparation/build-up, MA submission and post-MA dossier management. 

Development

• Review and preparation of MA dossiers;
• Definition of regulatory strategies for MA approval; 
• Conversion to eCTD format.

Pre-MA

• Preparation, submission and management of MA applications (EU and non-EU);
• Local representative as MAHs;
• Price and reimbursement applications;
• Regulatory support on the launch and marketing of medicines.

Post-MA

• Preparation, submission and management of variation and renewal applications of MA (EU and non-EU);
• Drug information management on Eudravigilance Platform (XEVMPD);
• Advertising regulatory support.