Pharmacovigilance Solutions

Apply compliant, risk-based operational and quality assurance (QA) pharmacovigilance (PV) approaches to ensure patient safety throughout product development and commercialization.

Our Services

Our PV operational and QA services and solutions ensure appropriate, actionable safety oversight of PV activities. We’re dedicated to open communication and collaboration required to build a cohesive team.

Founded and led by a quality assurance and compliance expert

Everything we do is rooted in dedication to customer focus, quality management, and the regulatory requirements designed to ensure data integrity and patient safety.

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:

PV Vendor Selection & QA Qualification
Operational Oversight of PV Vendors
PV Process & SOP Development
Full-Service PV QA
PV Master File Development Consulting
PV Operational Post-Audit & Inspection Remediation
Commercialization PV Strategy

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.

Our Vision For You

Establish infrastructure that supports GVP compliance.
  • Establish internal expertise that aligns with regulatory expectations for operational oversight.
  • Create and document internal processes that clarify internal roles and responsibilities, and the outsourcing model.
Build a fit-for-purpose PV quality system.
  • Establish practical processes and documentation that evolve with your clinical development and commercialization strategy.
  • Institute internal processes that optimize resources and demonstrate oversight.
Build PV operational knowledge that enables appropriate oversight of PV vendors.
  • Continuously improve industry knowledge and subject matter expertise.
  • Develop useful and efficient documentation of oversight.
Build a seamless case processing flow that includes all stakeholders in your PV universe.
  • Leverage our expertise to optimize PV vendor selection.
  • Clarify documentation and enhance clarity of your unique PV story.

Training Solutions

We offer a variety of PV training options, including company-wide PV and product complaint training, PV QA coaching and training, and more.

View our Services Menu for a detailed list of topics and options.

What Clients Are Saying

"I worked with Penelope as European Area Qualified Person for PV (EEA QPPV) and J&J’s deputy QPPV. She developed J&J’s PV compliance function at a time when it was not an easy task by a long shot. Penelope is an excellent team builder and a great person to work with. She has the attention for detail that is needed for compliance management, while simultaneously simplifying collection of compliance management data."

Arthur Meiners

Former European Area Qualified Person and Deputy QPPV, Johnson & Johnson

"There is an ever-present challenge to tie Quality, Pharmacovigilance, and strategy together. PDC is the resource that helps organizations accomplish this difficult task. I could not give a stronger recommendation for PDC. Bringing this team in will have an immediate positive impact on your business."

Doug Gentilcore


"Dedicated and experienced, PDC contributed immensely to the advancement of the organization."

John Harkins

Former Senior Director, GPV Operations Management and North American Compliance & Business Management, Otsuka Pharmaceuticals

Our Leadership

Penelope Przekop, MSQA, RQAP-GCP

Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.

How can we help you?

Reach out to schedule a consultation.