We're passionate about developing and executing risk-based strategies that result in fit-for-purpose corporate and regulatory compliance solutions. We believe that applying creative, innovative approaches to quality systems and assurance can make a positive, lasting impact on our industry's ability to ensure patient safety for decades to come.
Every company is unique. Building infrastructure, developing products, having oversight of vendors whose expertise you rely on, and following all applicable regulations in the process can be overwhelming. Our goal is to infuse our clients with confidence that all of the above is, and will be, executed and documented, as required by regulatory health authorities. Authentic and honest communication builds trust between both individuals and companies. The trust our clients have in us ultimately gives them that confidence.
PDC Pharma Strategy was founded in 2008 when Penelope Przekop began consulting after 19 years in the industry. Based on her work with numerous companies during a time of rapid industry change, Penelope recognized that emerging companies using new business models needed practical solutions for ensuring quality and compliance. In 2016, the company was rebranded to reflect her growing interest in developing and implementing innovative, fit-for-purpose quality and compliance approaches. This continues to be a key focus for PDC, in addition to providing industry standard quality assurance services, and more.
PDC Pharma Strategy is currently in a growth phase.
Change is on the horizon.
Penelope Przekop is a GxP Quality Assurance/Systems and Compliance Consultant with over 30 years of industry experience. Penelope has consulted for numerous top 100 pharma and biotech companies. She has held leadership positions at Covance, Novartis, Wyeth, and Johnson & Johnson as well as interim VP-level quality and compliance roles as a consultant. She has served as a Chief Compliance Officer.
Penelope holds an MS in Quality Systems Engineering from Kennesaw State University and a BS in Biology from Louisiana State University. She is a graduate of the Rutgers University Senior Leadership Program for Professional Women and the Smith College Customized Program for Women’s Leadership.
Jane Frost is a highly experienced clinical research professional with over 25 years of pharmaceutical industry experience. She has extensive experience in organizational leadership, quality management, training, quality assurance, and operational oversight. Her experience includes leadership roles at Pfizer and AstraZeneca. Jane holds a BScDipEd on Physiology and Biochemistry from Macquarie university. She is located in Australia.
Valerie Przekop joined PDC in June 2020. She provides ad hoc quality and compliance consulting to PDC clients. Valerie holds a MS in Biomedical Informatics, BS in Management Science & Engineering, and BA in Psychology from Stanford University, where she was a varsity student-athlete. She has co-authored articles for Clinical Leader and Life Science Leader Magazine.
Mimi Kim joined PDC in November 2021 as a Quality Assurance Specialist. She provides QA support to PDC clients in the areas of inspection readiness, document management, and planning and execution of electronic quality management systems. She is a registered pharmacist with 22 years of experience. She earned her degree at the Massachusetts College of Pharmacy and Health Sciences. She also has experience providing social services support as a certified social services designee.
Dorien Simon provides web and software development services for PDC clients. He received his BS in Computer Science from Stanford University and has worked as a software engineer at Google and Palantir. He’s the founder of Cusdom Agency, a software development agency, that builds custom software for small businesses and startups.
Joon Sung Park joined PDC in November 2021 as a Quality Assurance Specialist. He provides QA support to PDC clients in the areas of inspection readiness, document management, and planning and execution of electronic quality management systems. Joon earned a B.S. degree in Neuroscience from Boston College. He has several years of experience in the healthcare industry related to ensuring quality documentation and has technical experience in ophthalmic patient care.
Malou joined PDC in 2023. Prior to receiving her MBA from Nexford University, she earned a BA in Theatre Arts with a Minor in Speech Communication from University of the Philippines Baguio. Malou has over 20 years of experience in stakeholder management, public relations, project leadership, training, sales, marketing, and customer service.
Anisha Chaudhary joined the PDC team thru the Society of Quality Assurance (SQA) mentoring program. She is working with Penelope Przekop to strengthen her GCP and PV quality assurance knowledge and skills. Anisha has ~7 years of industry experience with companies including TaTa Consultancy Services, Takeda, and Shire. She has a B.S. in pharmacy and earned her M.S. in Project Management (concentration in Clinical Research) from Northeastern University in Boston, MA.
Our team of trusted, experience professionals is growing. Watch for new faces, coming soon!
We create risk-based solutions for your drug development
and post-approval quality and compliance challenges.
The best strategy is to proactively identify and execute compliant,
fit for purpose, solutions in anticipation of industry-standard challenges.