Tel: ++41 61 401 3652
Fax: ++41 61 401 3652

francois.schiltz@bluewin.ch

  Areas of Expertise  

 Regulatory Affairs and Marketing Authorizations in Europe

Due to our vast experience and good contacts with the European Health Authorities we can ensure that your investments in developing new products and in getting marketing authorizations have a greater chance of succeeding by using our consulting services.

We can assist you in deciphering the complex rules and regulations in the marketing approval process by advising you on how to:

• Enhance your understanding of the ongoing development of EU pharmaceutical regulations. 
• Pinpoint the difficulties in the approval procedures and adjust your application accordingly. 
• Reinforce your application for marketing approval of new or modified products. 
• Identify whether the products meet the requirements for a centralized process or mutual recognition process. 
• Enter into negotiations with regulatory agencies. 
• File orphan drugs applications. 
• Lessen the risk of your products failing to gain EU-wide approval via centralized process or via mutual recognition process.