FDA Interactions and Product Defense

Properly navigating the regulatory process is critical to the development of any new technology or pharmaceutical breakthrough. QST has nearly 30 years of experience with interacting with the FDA and preparing for approvals and compliance throughout the development process.

We can also assist with FDA/client meetings after helping clients prepare for product defense. Dr. Quiring and Dr. Mathisen have years of experience in face-to-face meetings with the FDA and Dr. Quiring has testified as an expert witness concerning the statistical interpretation of study data.

QST can provide the following services to help you successfully meet and exceed regulatory requirements for FDA submissions:
  • Strategic preparation for FDA meetings
  • Participation in FDA/Client meetings
  • Legal representation as expert witness