Regulatory Affairs Unit

"It's all about strategy"

The TFS Regulatory Affairs Unit has extensive experience in managing all aspects of regulatory services. This unit supports a product from drug development phase throughout the clinical trials to market authorisation and product maintenance.
The services include regulatory advice, preparation of documentation, submission and liaison with Competent Authorities.

Our in-depth knowledge of the national regulatory requirements as well as the European regulations assures that the entire product life cycle will run smoothly and efficiently.

Regulatory Affairs Managers at TFS have many years of experience from working with large European, Asian and US pharmaceutical industries and they are continually updated on the latest developments concerning regulatory affairs issues.

The Regulatory Affairs Unit has a long and productive track record in liaisons with many of the most respected competent authorities throughout Europe and is frequently preparing, coordinating and conducting national and CHMP scientific advice meetings with the regulatory authorities and pharmaceutical industry.

The Regulatory Affairs Unit can provide the following services:

• Regulatory strategy and general regulatory advice
• Clinical trial applications, including umbrella applications
• Orphan drug designation
• Marketing authorisation applications
• Application preparation
• Product information writing
• Product maintenance
• Liaison with competent authorities

• Transfer data from US format to EU format
• Regulatory due diligence
• Regulatory Intelligence
• Scientific advice meetings with national competent authorities and the EMEA
• Pre-submission meetings with EMEA
• Legal representative in Europe
• On-Line regulatory support

The services provided by the Regulatory Affairs Unit can be contracted as a whole or in part and are also available through our Contract Placement Concept.