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Research on Prescription Drugs
Regulating Consultants to the Pharmaceutical Industry

Whether you are looking to establish a comprehensive Risk Minimization Action Plan for a new drug or for one that already has been approved, or are thinking about seeking a scheduling or rescheduling action, Prescription Drug Research Center (PDRC) is your best choice for experienced and confidential help.

The Prescription Drug Research Center is located at the Mason Enterprise Center, a part of George Mason University, in Fairfax, Virginia. As a member of the Mason Enterprise Center, PDRC has access to scientific and technical resources of this major university in the Washington, D.C. area. Moreover, PDRC's affiliation with Bensinger Dupont & Associates provides access to BDA staff and resources in Chicago, Rockville, Little Rock, and San Diego.

• Risk Minimization Action Plans
• Product Surveillance Programs
• Expertise in CSA (Title 21, US Code)
• Regulatory & Drug Scheduling Issues

• Abuse Potential Assessments
• Special Population Surveys
• Government Liaison
• Forensic Drug Extraction Studies

• Monthly, Quarterly, and/or Semi-Annual Reports
• Nationwide Rapid Response Team Capability to Address Emerging Crises
• Liaison Services (Briefings) for Federal Regulatory Agencies (DEA, FDA)
• Educational (CME) Presentations on Product Surveillance
• Expert Advice on Scheduling and Rescheduling Actions Under the CSA
• Specialized Forensic Extractions and Abuse Potential Assessments

Who We Are

PDRC is a unique consulting firm comprised of nationally known experts in regulatory drug control. PDRC is a subsidiary of BDA, a well-established professional services company headed by Peter B. Bensinger, former Administrator of the Drug Enforcement Administration, and Robert L. DuPont, M.D., former Director of the National Institute on Drug Abuse. John J. Coleman, Ph.D., PDRC's President, is retired from DEA where he was Assistant Administrator for Operations. Robert P. Bianchi, B.S., PDRC's Vice-President for Scientific and Technical Affairs, retired from DEA as director of its special testing and research laboratory. PDRC shares additional technical, administrative, and professional staff with BDA. Contact us for more information.

What We Do

PDRC works closely with drug manufacturers beginning with pre-NDA product development meetings when potential abuse issues can be ascertained quickly and reliably using a variety of "kitchen chemistry" experiments modeled after procedures developed by the DEA's special testing laboratory. PDRC's experts in forensic science and regulatory policy quickly determine what happens, for example, when your new oral drug is crushed and solubilized for injection, or how an abuser might extract active ingredients from your modified-release drug using common solvents available at hardware, paint, auto supply stores, or perhaps, a local pharmacy or supermarket. Knowing a product's abuse liability is the first step in designing a comprehensive RiskMAP that will satisfy the FDA's safety concerns during the NDA review.

Contact us in Fairfax, Virginia, for research on prescription drugs for the pharmaceutical industry. (703) 277.7734

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Prescription Drug Research Center
4031 University Drive, Suite 200
Fairfax, VA 25203-3409

Phone: (703) 277.7734
Fax: (703) 277.7730
Email: