Drug regulatory affairs

 

Regulatory Plus offers the following services:

 

Development of new drug products:

• Preparation regulatory strategy
• Planning of meetings with the authorities, preparation of documentation and participation in meetings
• Preparation of application for Orphan Designation in the EU and USA
• Preparation of clinical trial application in the EU and the USA
• Preparation of investigators brochure
• Preparation of application for marketing authorisation
• Preparation of response document to the authorities

Established products:

• Preparation of variation applications/amendments and response to the possible questions
• Preparation of annual report
• Preparation of drug master file