About

Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial expertise.

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Ms. Przekop began her career serving in preclinical research, regulatory affairs, and quality assurance positions of increasing responsibility at Hoechst-Rousell. She went on to hold leadership roles at Covance, Wyeth (acquired by Pfizer in 2009), Johnson & Johnson (J&J), and Novartis. She developed and oversaw the first global pharmacovigilance quality and compliance departments established for both Wyeth and J&J.

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During her career, Ms. Przekop established and oversaw numerous global GxP quality management systems, quality assurance processes and groups, audit programs, and regulatory inspection readiness programs. She has conducted numerous GxP mock inspections and facilitated numerous regulatory inspections. She serves as fractional Chief Compliance Officer and Data Protection Officer for industry clients.

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Ms. Przekop received her MS in Quality Systems from Kennesaw State University’s School of Engineering and 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. She has authored quality management-related books published by McGraw-Hill and Productivity Press.

Janet Flisak is a strategic, results driven clinical research professional with over 25 years of industry experience. 
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She began her career in critical care nursing, then entered the industry as a medical writer with advancing roles in clinical operations and clinical development. To date, Janet has served as a global team leader with oversight of trial managers in conducting international studies, with primary focus on Phase 3. Her broad understanding of local and global regulations has contributed to her strong record of overseeing the compliance of numerous complex studies.

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In addition to authoring numerous protocols and clinical study reports, Janet has contributed to several NDAs and BLAs. Her expertise encompasses multiple therapeutic areas, including oncology, hematology, immunology, endocrinology, rheumatology, psychiatry, sexual dysfunction, rare disease, NASH, COVID-19, and immuno-oncology. She has both large and small molecule experience spanning Phase 1 (including first-in-human) through Phase 4.

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Janet is a registered nurse who holds an MBA from University of Phoenix; a BS in Business Administration and Marketing from University of Pennsylvania, Wharton School of Business; and a BS in Nursing from Reading Hospital School of Nursing, Albright College.

Valerie Przekop is a dynamic industry professional with a strong background in data science, operations, and quality systems. She joined PDC in 2020. Before assuming her current role, Valerie served as a Quality Assurance & Compliance Consultant at PDC Pharma Strategy, where she provided pivotal support in securing favorable FDA inspection outcomes and developing foundational quality management systems. Her technical skills encompass a wide array of programming languages and tools, along with a deep understanding of machine learning and data analysis. She has worked with companies of varying sizes and specialties, including Elevance Health, Boehringer Ingelheim, ILiAD Biotechnologies, ARTMS, and Lucille Packard Children's Hospital.

Valerie holds an MS degree in Biomedical Informatics from Stanford University School of Medicine, as well as dual Bachelor’s degrees in Management Science & Engineering and Psychology from Stanford University. She is Lean Six Sigma Yellow Belt Certified and has been published in Life Science Leader Magazine.

With over 25 years of clinical quality and compliance experience, Maryrose Petrizzo has demonstrated her expertise across various remote and on-site roles within emerging and established companies. She boasts a comprehensive skill set that includes quality oversight of drug, biologic, and medical device clinical trials; regulatory inspection readiness; quality systems development and implementation; risk, record, and issue management; clinical due diligence; pharmacovigilance; and Good Clinical Practices (GCP).  

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In addition to establishing / managing clinical inspection readiness programs for FDA, EMA, and MHRA regulatory agency inspections, Maryrose has consulted for NIH / NIAID / DAIDS. Her expertise encompasses multiple therapeutic areas, including CNS, cardiology, neurology, gastroenterology, oncology, blood products, plasma, and rare diseases.

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Equipped with Cyntegrity Black Belt training in Risk-Based Quality Management, Maryrose offers a range of training services covering ICH E6 GCP, ISO 14155:2020, inspection readiness, mock inspection conduct, Subject Matter Expert interviews, protocol deviation management, sponsor oversight, and clinical trial risk management.

As PDC’s consulting attorney, Robert ("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.

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Bob previously served as Partner and Co-Chair of the Food & Drug Practice and Dietary Supplements industry team at Arnall Golden Gregory (AGG); he was also a member of the AGG Healthcare Practice and Life Sciences industry team. 

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Currently, Bob is Partner and Co-Chair of the Regulatory Group at Amin Wasserman Gurnani.

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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.

Mahendra M. Mhamunkar is a seasoned GMP consultant and qualified Lead Auditor with a rich background in pharmaceutical manufacturing. With 24 years of industry experience, Mahendra specializes in quality assurance, quality control, regulatory affairs, training and development, and third-party audits.  

His career is distinguished by his role in representing companies during regulatory inspections, including those by the USFDA, EUGMP, MHRA, PMDA, TGA, CDSCO, WHO-Geneva, EU-GMP, MFDS Korea, and other prominent regulators. Mahendra has conducted over 650 audits across approximately 20 countries, spanning drug product manufacturing units (OSD, Injectables, Ointments, Liquids), APIs, KSMs, medical devices, CROs, and laboratories.  

Mahendra is recognized as a subject matter expert in quality control and data integrity, with a significant tenure at Teva Pharmaceuticals — one of the world’s largest multinational pharmaceutical companies. Under his consultancy, API facilities have successfully completed inspections by the USFDA, EUGMP, PMDA, and COFEPRIS with zero observations.  

Additionally, he has designed and qualified a sterile oncology formulation plant for dry powder injectable products, meeting the USFDA’s stringent requirements. Mahendra's third-party audit reports are notably accepted by Qualified Persons (QP) in Europe for batch release, affirming his status as a leader in the field

Ms. Malcolm is an independent QA Professional with nearly 30 years of experience in the pharma industry, including 24 years of QA focus. She has extensive experience in GCP and PV auditing against EU, US and other regulatory requirements, covering Phases I-IV drug, device, and pediatric trials and all major therapeutic areas. Ms. Malcolm is an expert in inspection management, including experience with FDA, MHRA, PMDA, and many other EU local regulatory agencies.

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She brings excellent technical knowledge, communication, project management, time management, prioritization and organization skills, and an ability to manage complex issues and challenges.

Mimi Kim is a registered pharmacist who brings over 20 years of leadership experience and knowledge. She joined PDC in November 2021 as a Quality Assurance Specialist. 

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Mimi supports clients in audit management, inspection readiness, document management, and planning and executing electronic quality management systems. Her people management and mentoring skills include developing and managing externship programs.

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Mimi holds a BS in Pharmacy from the Massachusetts College of Pharmacy and Health Sciences. She is a certified Social Services Designee.

Jane Frost is a 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. She has held leadership roles at Pfizer and AstraZeneca. Jane holds a BScDipEd on Physiology and Biochemistry from Macquarie university.