Strategic solutions, engineering precision

At the core of our technical services is a simple commitment: helping clients overcome the complex engineering and validation challenges that stand between innovation and impact.

At Critical Mass, we take an cutting-edge risk-based approach to commissioning and qualification, integrating seamlessly into client teams to deliver programs that are both efficient and compliant. Our engineers bring not only deep technical expertise, but also practical experience with electronic validation systems across both single-use technology (SUT) and stainless-steel facilities.

From process system start-up to full qualification, we focus on solutions that are rigorous, reliable, and tailored to the realities of your operation—ensuring every system is ready to perform, and ready to pass inspection.

About Critical Mass Consulting

Critical Mass Consulting partners with biotech, pharma, and medical device companies to streamline facility startup, strengthen regulatory compliance, and accelerate time-to-market. We specialize in Integrated CQV, validation engineering, and full lifecycle support for GMP manufacturing environments.

What Makes Us Different

We integrate engineering, regulatory strategy, and program management into a single, unified CQV framework. This approach eliminates handoff delays, reduces project risk, and improves execution efficiency from design through commercial readiness.

Who Do We Support?

  • Cell and gene therapy facilities

  • Biotechnology companies

  • Pharmaceutical manufacturers

  • Medical device organizations

  • CDMOs and emerging platforms

  • Early-stage ventures scaling operations

Our Leadership Team

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Vishwas Patel

  • Joining the team in mid-2025, Vishwas brings over 13 years of deep technical expertise in the life sciences industry, specializing in Risk & Science based Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), Data Integrity, Technology Transfer, Process Characterization, Engineering, & Validation, and QMS compliance. Known for his strategic project leadership and hands-on problem-solving approach, Vishwas has successfully led numerous high-impact initiatives across biotech and pharmaceuticals. With a strong passion for innovation, he actively explores the evolving intersection of AI and life sciences, continuously staying up-to-date on industry trends and emerging technologies.

    Outside of his professional pursuits, Vishwas enjoys a well-rounded life filled with travel, music, sports, and time with loved ones. Whether it’s exploring new countries, capturing the world through the lens, playing cricket, reading while savoring exotic teas, playing his bamboo flutes and guitar, or experimenting in the kitchen, he embraces every opportunity for curiosity, creativity, and connection.

    Fun Fact: Vishwas is a passionate traveler and nature photographer who enjoys teaching and inspiring others through professional photography.

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A smiling man with a mustache and a shaved head, wearing a black polo shirt with a company logo, sitting indoors.

Andrew Matheson

Randy Hartley

  • The founder and General Manager of Critical Mass Consulting, Andrew built the company centered around Core Values he believes in. As a Senior Consultant, Andrew brings a wealth of experience to multiple client projects as he manages CMC. As the General Manager of CMC, Andrew participates in all internal teams within the company to ensure the company continues to thrive. He loves to play music no matter how it sounds, stares at his bicycles longingly, and will happily watch basketball and football all day if he can.

    Fun fact: Andrew is a SoCal kid at heart with a strong passion for New England sports teams.

  • A long time member of Critical Mass Consulting, Randy has worn a myriad of hats since joining in 2019. As a Senior Consultant with decades of experience in the life sciences industry, Randy has managed various projects across several client sites in different sectors. Internally, Randy currently serves as the head of the Sales and Recruiting divisions, helping grow the business through both facets using his vast experience. In his time off Randy enjoys reading to continue learning new things, backpacking through the wilderness and riding his sweet motorcycle.

    Fun fact: Randy served as a Special Forces commander for many years.