We provide direct submissions to the FDA either via our own access to the FDA Electronic Submissions Gateway (ESG) or through our preferred or your recommended eCTD vendor. We provide regulatory agency liaison services with industry standard record management practices.

• Coordination of NDA Submissions
• Preparation of ISS/ISE and other clinical sections
• Compilation of NDA sections
• Quality assurance

request for proposal

In my dealings with Prosoft Clinical as CEO of Encore and other organizations over the last 10 years, Prosoft Clinical have always been thorough, insightful, and timely. They are a professional group of individuals that understand not only the development process, but how to connect those activities with an eventual commercial outcome. We have relied on their expertise and customer oriented service to help us move various projects forward and have never been disappointed.