Founded in 1995, Prosoft has completed numerous projects/studies from the pharmaceutical, biotech, and medical device industries in therapeutic areas including dermatology, women’s health, cardiovascular, respiratory, allergy, immunology, CNS, and oncology. Our team members have worked together for over 20 years. Our track record from our careers in the sponsor arena and while at Prosoft includes not only all of our full-service clinical studies but also the regulatory agency interactions leading to the marketing approvals. 

Prosoft Clinical offers focused consulting in all areas of pharmaceutical product development, from concept and planning to execution and submission. As a combined workforce, Prosoft Clinical can support the activities required for the success of your pharmaceutical and medical device programs.

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.

~ From DH, a sponsor company….