• Advice on strategic and operative aspects of drug development
• Advice on the registration process
• Development of registration strategies
• Clarification of correct contact officials
• Advice on timing of initial contact with the registration authorities
• Facilitation of the initial contact with registration authorities
• Support in preparation of meeting with officials
• Negotiation of all steps to registration, and advice and support in their implementation
• Support in all phases of contacts with the authorities, including dossier preparation and submission
• Follow-up of submissions
• Assistance with contacts to the US Food and Drug Administration (FDA)

 

Move fast towards launch!

Regulatory.Affairs@ams-europe.com

 

< Our team