Quality Solutions

Ensure quality and compliance with innovative, risk-based, fit-for-purpose solutions.

Our Services

Our expertise and experience spans GxPs and therapeutic areas

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:

Quality Management Systems
Quality Risk Management
Vendor Qualification & Oversight
Clinical Quality Assurance
Management of Audit Programs & Audit Execution
Quality Event & CAPA Management
Inspection Readiness, Facilitation & Support

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.

In addition to the areas listed above, we offer an innovative full-service, plug-in QA functional model. Contact us to find out if your company is a candidate for this unique industry solution.

View our Services Menu for a detailed list of our solutions.

Go here to explore our pharmacovigilance quality and operational services.

Our Vision For You

Align compliance and corporate strategies.
  • Develop a flexible framework that supports and documents compliance.
  • Proactively include quality assurance expertise to ensure GxP data integrity.
Build a fit-for-purpose Quality Management System (QMS).
  • Establish a practical QMS that pivots and evolves with the clinical development program.
  • Institute processes that optimize resources and demonstrate oversight.
Establish a risk-based approach that establishes proof of compliance.
  • Team with an expert to ensure adequate risk-based oversight.
  • Build a documented compliance profile throughout the drug development process.
Establish a reliable inspection readiness approach.
  • Leverage our existing inspection readiness materials.
  • Deploy our innovative mock inspection approaches and activities.

Training Solutions

We offer a variety of training options in the quality and compliance space.

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

What Clients Are Saying

"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

CEO, ARTMS Inc.

"Penelope’s greatest asset is her ability to maintain composure under the wide variety of situations that may arise in a global quality organization (i.e., unannounced regulatory inspections, urgent requests for data, etc.)."

Jennifer Shingle

Director of Regulatory Affairs, Business Continuity, Standards & Training, Merck

"PDC’s knowledge of process excellence and regulatory guidelines is beyond impressive and has been invaluable to my team and clients.
Any company would be lucky to have the opportunity to work with PDC."

Liimu McGill

CEO, LSM Consulting

Our Leadership

Penelope Przekop, CEO, MSQA, RQAP-GCP

Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial expertise. During her career, Penelope 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 received her MS in Quality Systems from Kennesaw State University’s School of Engineering and BS in Biology from Louisiana State University. She has authored quality management-related books published by McGraw-Hill and Productivity Press.

How can we help you?

Reach out to schedule a consultation.