Kinesis provides expert opinions on regulatory-related questions and procedures and liaises to regulatory authorities.

What we can offer for your chemically synthesized products, biotechnological products and biologicals:

• Consultancy by experienced people on regulatory issues within your drug development process
• Preparation of CTD Module 1 and 2
• Submission of the dossier and contacts with Regulatory Agencies
• Assistance in and preparation of scientific advice/IND submissions or meetings

  Fact sheet