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)