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Working together for over 15 years, the PSPG core has NEVER had an NDA rejected and ALL of its completed phase III trials have been successful. Together, we have worked on trials and have developed compounds in several therapeutic areas: CNS, including Alzheimer’s, Vascular Dementia, Seizure Disorders, Diabetes, Metabolism, and Cardiovascular.

One of our submissions earned awards both in the United States and abroad: FDA’s CNS Division reviewed and approved the drug in record time, and this has been memorialized by a Recognition Plaque awarded by, and displayed at, the FDA.  This product also received the United Kingdom’s prestigious Prix Galien Special Commendation for “Excellence and Innovative Product.” In addition, in 1998, a scientific article about the drug by a core PSPG member was ranked the 11th most cited biomedical publication in the world.

Over the past 12 years, we have submitted and have received approvals of Five NDAs and a number of MAAs. Unlike groups that are formed by senior people with little “hands on” experience drawn from large pharmaceutical companies, PSPG’sseasoned professionals understand your business from the ground up. Its members have twice initiated and built pharmaceutical divisions (and their required supporting infrastructure: Clinical, Regulatory, Data Management, CMC, Professional Servics, Promotional Materials Review, etc.) for major pharmaceutical companies. Doing the majority of the work in-house, the PSPG team possesses a strong knowledge base of clinical research experience, from IND through market launch and support. PSPG is a “small company” that time after time, surpasses “large

company” results.

Supplementing its pharmaceutical expertise, PSPG can share communications, security, and project management techniques. Savings afforded by our cost-containment methods often offset or exceed

charges for our other services.  Not all drugs are approvable, but if yours is, PSPG will design and implement the best and quickest route through the regulatory approval process.

As a small group, PSPG limits its activities in order to maintain its high quality. PSPG treats each client as its only client, so you are never second, as in larger company relationships. With PSPG, you are always first!

In 2005, the FDA approved only 13 new molecular entities and one new biologic, from thousands of products in development. When you are ready to be among this select group of pharmaceutical industry

innovators, let PSPG know, and perhaps we can do great things together.

Contact PSPG’s President, Lawrence T. Friedhoff, MD, PhD, FACP, at  for more information.  Please see PSPG’s List of Services