Penelope Przekop- Quality Entrepreneur, Expert, and Writer

Pharmaceutical firms encounter a variety of commercial, operational, and technical difficulties that are made even more difficult by regional and international regulatory frameworks.  Similar to those in other sectors, pharmaceutical consulting firms work closely with businesses to mitigate and address complex problems while adhering to the rules.

Tell us a little bit about your professional background.  

I’m a corporate quality management professional, business owner, and author. I’ve worked with and held executive roles at hundreds of biotech and pharmaceutical businesses throughout the course of my more than 30-year career. Many Big Pharma firms, such as Glaxo Smith Kline, Johnson & Johnson, Merck, Novartis, Pfizer, and Wyeth, as well as medium-sized and smaller biotech, pharmaceutical, and vendor firms were among them. I am PDC Pharma Strategy’s founder and CEO.

I started my career in pre-clinical research thanks to my BS in biological sciences. I had the chance to pursue cross-training in quality assurance while working in the lab. That opened the door for a move into that department about a year later. As I progressed through different research and development fields, I placed a strong emphasis on quality assurance/management and compliance.

I obtained my MS in quality systems engineering after learning about the science of quality management in the late 1990s. My career’s focus became more clear at that point. I developed a fascination for the potential benefits that the science that produces high quality may have for all facets of pharma, and that passion still exists today.

Additionally, I’m the author of Five-Star Career: Define and Build Yours Using the Science of Quality Management (Productivity Press) and Six Sigma for Business Excellence (McGraw-Hill). In 2018, my daughter Phoebe Horak and I co-founded Bra in a Box, which has been highlighted in Real Simple and New York Magazine. 

Tell us a little bit about your business and how it functions within the current pharmaceutical sector.

A consultancy company called PDC Pharma Strategy provides assistance to the heavily regulated pharmaceutical sector. Throughout the entire medication development and product lifecycle, we develop and implement risk-based strategies that ensure thorough worldwide regulatory compliance.

To establish regulatory compliance strategies that can easily scale and pivot with the trajectory, twists, and/or turns that come, as we all know they will, we are especially interested in collaborating with customers at the strategic level as early in the drug development as possible.

We also collaborate with businesses at different phases of the drug development process to find gaps and suggest ways to enhance productivity, documentation, and compliance. All of these initiatives help the industry achieve its ultimate objective of maintaining the public’s safety while creating new, secure pharmaceutical products.

PDC Pharma Strategy’s goal is to assist pharmaceutical and biotechnology businesses in creating and implementing practical, effective, and scalable quality and compliance strategies and processes that protect patient safety and data integrity while simultaneously advancing corporate objectives.  

How do you make the decision to expand the business?

The industry required new tactics as a result of the significant technological advancements that started in the middle to late 1990s.  Pharma realised the necessity for fresh approaches in the areas of finances, corporate structure, human resources, supply chain, information technology, and operational procedures as a logical evolution.

But in terms of strategic change, one important issue was overlooked: regulatory compliance. The quality and compliance methods of the 1980s and 1990s mostly persisted, despite the rest of the industry changing to become the 2022 pharmaceutical landscape that exists today. 

I couldn’t stop thinking about this industry gap, how and why it came to be, and how it may be bridged to better match quality and compliance techniques with the present industry environment. PDC Pharma Strategy was founded as my professional interests and consulting work began to become more focused on quality and compliance strategy, even though I started my consulting career in 2008.

I started to understand that, given the changes that have led to a significantly different industry landscape than the one I joined in the late 1980s, I had acquired the specialised skill set necessary to assist businesses and the sector in developing creative regulatory compliance strategies to ensure compliance.  

Why is it claimed that every company’s growth depends critically on its workforce? Tell us a little bit about your team.

Each employee of a PDC Pharma Strategy is a representative of the business and enhances its culture as well as its capacity to uphold and carry out its vision and goal. Starting at the top and having a way to permeate every level and area of the organisation, setting the stage for that mentality and culture is essential. The harder it is to accomplish something, the bigger the organisation.

The science of quality management offers a tried-and-true solution to that problem. One of the main issues is that many executives are unaware of the need of laying the groundwork for this when the business is small and young. Once something has reached its full potential, it is much more challenging to mould it into the desired shape.

PDC Pharma Strategy is a small consulting company with fewer than ten employees.  I enjoy working with and mentoring talented, young people because they provide a new perspective and the technical abilities to complement my in-depth understanding of the sector. It’s a fantastic relationship for coming up with creative ideas to bring about longer-term change.

I’ve created a culture of cooperation, education, innovation, and effectiveness. Having said that, expertise is invaluable when it comes to carrying out what is necessary in the near to mid-term. PDC Pharma Strategy has a sizable network of knowledgeable industry consultants who may work together as needed to meet the demands of our clients. PDC Pharma Strategy, on the other hand, emphasises industry knowledge combined with a burst of originality and a tonne of common sense.  

“Choice means giving up something you want for something else you want more.”  

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