In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
We apply a broad and deep understanding of the industry, its history, the current landscape, and our vision for a healthier future to proactively address your challenges in the following areas and more:
Optimized AI Query Crafting: Enhance the quality of your AI interactions with our expert assistance. We’ll guide you in framing ChatGPT and other AI questions to yield insightful, accurate, and high-quality results.
View our Services Menu for a detailed list of our solutions.
What Clients Are Saying
I could not give a stronger recommendation for PDC. Bringing this team in will have an immediate positive impact on your business."
CEO, ARTMS Inc.
CEO, LSM Consulting
Former Senior Director, GPV Operations Management and North American Compliance & Business Management, Otsuka Pharmaceuticals
Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial expertise. Her diverse experience includes developing and implementing strategic fit-for-purpose corporate compliance solutions for late phase development companies, including due diligence and IPO readiness. She has served as Fractional Corporate Compliance Officer and Data Protection Officer. Her unique blend of GxP, corporate compliance, and business development knowledge enable her successful leadership throughout drug development and commercialization.
As PDC’s consulting attorney, Bob draws from the extensive experience he gained at the FDA where he was responsible for performing policy analysis and evaluations while also providing skillful advice on compliance and enforcement issues (such as Warning Letters, seizures, injunctions, import detention/refusal, etc.). During this time, he was active in a variety of agency working groups, including the Agency-wide Marijuana Working Group, the Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. Bob has also served in both the Commissioner’s office and the Center for Drug Evaluation and Research (CDER), where he worked in the areas of health fraud, over-the-counter drugs, and pharmacy compounding.
Bob is a partner and co-chair of the Food & Drug practice and Dietary Supplements industry team at (AAG). He also serves as a member of the Healthcare practice and Life Sciences industry team.
He holds a JD degree from Widener University Schools of Law, an MS degree in Cell/Cellular and Molecular Biology from the University of Hawaii at Manoa, and a BS degree in Pharmacy from the Philadelphia College of Pharma and Science