Regulatory Operations

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.

“I enjoy working for a small, virtual pharma company. But sometimes things get a bit hectic and we need a more help – it could be in Regulatory, or CMC or Clinical. It could be an extended project or just a few hours here and there. Finding the right resource than can provide consistent quality work and performance for a variety of therapeutic areas, and be flexible with our crazy timelines was, of course, difficult. Until will found Prosoft Clinical about four years ago. Prosoft has experienced, professional and very friendly staff that can handle anything: from Project Management for FDA meetings, ANDA/NDA annual report submissions, product development strategies, Labeling review, to literature searches. One of the best decisions I have made.”