What We Do

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For well over a decade, the Prescription Drug Research Center, LLC, (PDRC) has been helping commercial registrants meet their DEA responsibilities under the law. PDRC’s knowledgeable experts and partner firms have decades of first-hand experience working with industry to bridge the information gap on drug regulatory policies. Whether it’s helping companies to develop abuse-deterrent formulations or advising drug manufacturers and distributors on how to comply with DEA requirements, PDRC is prepared to provide its services to clients quickly and confidentially.

PDRC has partnered with America’s largest and most respected DEA-registered private forensic laboratory to perform PDRC-designed testing in accordance with Food and Drug Administration (FDA) guidelines for the evaluation and labeling of abuse-deterrent opioids.1 In addition, to better serve its institutional clients, PDRC has partnered with the world’s largest strategic consultancy and auditing firm to include PDRC-designed specialized compliance and regulatory assessments as part of scheduled comprehensive audits of corporate services.

• Expertise in compliance and regulatory matters
• Design consultants for abuse-deterrent formulations
• Maximizing drug scheduling and labeling concessions
• Performing Category One Laboratory Manipulation & Extraction Studies*
• Including drug diversion risk assessments in corporate audits

* Per FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling April 2015

[1] Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. April 2015.