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“Proven Clinically Effective”

The design, management, and implementation of the drug approval process is a labyrinth fraught with problems for the inexperienced. In an industry where success is rare, Pharmaceutical Special Projects Group (“PSPG”) has an unsurpassed record of achievement. PSPG has the knowledge and expertise to guide your company through the complex and often byzantine drug development and approval processes. PSPG is a consortium of professionals with over a hundred collective years of successful experience in the pharmaceutical industry. The core members of PSPG are those primarily responsible for the development and US/European regulatory approvals of drugs currently selling over $4 billion dollars annually.

 

We have many years of experience SUCCESSFULLY getting drugs approved by regulators all over the world.  We have never had an NDA rejected and all our completed phase III trials have been successful.  The products we’ve developed sell over $4 billion per year.

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There were only 19 new molecular entity and biologic approvals in 2007 and a recent FDA audit revealed that the strongest predictor of a prompt approval of a new drug was a history of prior new drug approvals.  If you want to maximize your chances of approval, consider contacting us.

Lawrence Friedhoff, MD, PhD, FACP

President and CEO

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