THIRTY YEARS OF BUILDING WHAT'S NEXT.
Built on Rigor. Driven by Purpose.
When Robert E. Chew founded Commissioning Agents in 1996, the practice of validation in regulated industries was due for a reckoning. Paperwork-heavy, schedule-bloating and often disconnected from real operational outcomes, the status quo wasn’t working. Bob knew it could be better — and set out to prove it.
Drawing on his background as a Navy submarine engineer, where every instrument, control function and interlock on a nuclear reactor could be tested and documented in a matter of hours, he brought that same discipline and rigor to life sciences. What emerged was a new standard for commissioning, qualification and validation — one grounded in science, risk-based thinking and a relentless focus on making facilities actually work.
Thirty years later, CAI stands at the intersection of operational excellence and forward-looking innovation. The company has grown from its CQV roots into a global force helping organizations across life sciences and mission critical industries navigate everything from foundational readiness at a single site to digital transformation across complex global networks. Through partnerships with organizations like ISPE, PDA and NIIMBL, CAI continues to translate what’s emerging in the industry into what works on the ground. That foundation in life sciences shaped more than expertise in one sector. It built capabilities in rigor, systems thinking, risk-based execution and operational readiness that apply across a range of mission critical environments and high-stakes industries.
But the true measure of the impact from CAI impact isn’t in the numbers alone. It’s in what those numbers represent — medicines reaching patients faster, mission critical operations running with confidence and organizations equipped to face whatever comes next.
30 YEARS. IMMEASURABLE IMPACT.
3T
Every piece of equipment CAI validates has a life far beyond the facility floor. When we validate a dosage form machine, that machine may produce a billion doses over its service life — medicines that reach patients around the world. Across 30 years and roughly 3,000 validated machines, CAI has helped enable an estimated 3 trillion doses. That’s the real measure of our work.
$1.7B
IN SERVICES DELIVERED OVER 30 YEARS
$1.5B
IN LIFE SCIENCES LABOR SERVICES
3K
DOSAGE FORM MACHINES VALIDATED
30
YEARS OF OPERATIONAL READINESS EXPERTISE
64
Client Sites Served
* Figures reflect CAI internal data and reasonable estimates accumulated over 30 years of operations, 1996–2026.
"Humankind deserves affordable, available and high-quality therapies."
Robert E. Chew, Founder & Chairman of the Board, CAI
COUNTLESS SITES. ONE MISSION.
Every piece of equipment CAI validates has a life far beyond the facility floor. When we validate a dosage form machine, that machine may produce a billion doses over its service life — medicines that reach patients around the world. Across 30 years and roughly 3,000 validated machines.
THREE DECADES IN THE MAKING
1996
CAI Founded
CAI founded with a project involving critical facility upgrades for life-saving product inventory housing.
1997
FDA 21 CFR Part 11
Electronic records and signatures rule reshapes GMP documentation across the industry.
2000
CAI completes its first $1M project
2001
ISPE C&Q Baseline Guide
Reframes validation as an engineering discipline, directly influencing CAI’s methodology.
2003
FDA cGMP for the 21st Century
FDA launches a science- and risk-based manufacturing initiative, shifting away from paperwork-driven compliance.
2005
ICH Q8 Pharmaceutical Development
Introduces Quality by Design, defining CQAs and CPPs as the foundation for modern GMP facility design.
2006
Puerto Rico LLC
The first CAI subsidiary, establishing a footprint in the island’s booming pharmaceutical manufacturing sector.
2007
ASTM E2500 Published
Formalizes the risk-based approach to pharma/biopharma manufacturing systems that CAI championed from day one.
2008
Transformation to ESOP
CAI becomes employee-owned, aligning the team’s interests directly with client success and quality.
2008
ICH Q9 & Q10 Finalized
Quality Risk Management and Pharmaceutical Quality System guidelines complete the ICH quality trilogy.
2010
Hyperscale Data Center Era
Amazon, Google, and Microsoft begin rapid global expansion, driving demand for mission-critical commissioning expertise.
2011
Global Expansion
CAI establishes offices in Ireland, Singapore, and Shanghai — spanning 3 continents in a single year to support growing international client demand.
2011
FDA Process Validation Guidance
Revised guidance adopts a lifecycle approach aligned with ASTM E2500, accelerating adoption of science-based commissioning.
2013
Largest Project To Date
CAI leads commissioning for a $1.5B Covington, GA project (largest to date), supporting North American expansion across multiple ownership transitions (Baxter → Baxalta → Shire → Takeda). Revenue surpasses $50M.
2014
Malaysia SDN. BHD.
Technical & Consulting entity in Southeast Asia, expanding reach of CAI into high-growth biopharma markets.
2015
First Data Center Project
CAI awarded first data center project for Microsoft in Ireland, marking the expansion into mission-critical infrastructure.
2015
EU GMP Annex 15 Revised
Aligns European GMP requirements with ICH Q8/Q9/Q10, driving global harmonization of commissioning standards.
2019
ISPE C&Q Guide, 2nd Edition
Integrates ASTM E2500, ICH Q8/Q9/Q10, and EU Annex 15 into the definitive science- and risk-based GMP standard.
2020
Continued Global Expansion
CAI opened new regional locations in Australia, Korea and Switzerland. CAI exceeds $100M in revenue.
2020
mRNA Vaccine Manufacturing Scale-Up
Emergency authorization of Pfizer-BioNTech and Moderna triggers the fastest global pharma manufacturing build-out in history.
2021
CEO Transition
CAI completes leadership transition from founder to seasoned executive and plays a critical role in accelerating COVID-19 vaccine delivery to market. The company continues expansion into the United Kingdom and establishes a presence in India.
2021
Cell & Gene Therapy Boom
Rapid FDA approvals of CAR-T and gene therapy products drive unprecedented demand for specialized GMP facility readiness.
2022
Operations Consolidation
CAI closed operations in Malaysia and Puerto Rico as part of strategic right-sizing of the organization.
2022
AI Infrastructure Investment Surge
Generative AI adoption accelerates global data center construction, elevating mission-critical commissioning as a strategic imperative.
2023
Japan K.K.
CAI opens a new regional entity in Japan, completing a global presence across four continents.
2023
ICH Q9 R1
Quality Risk Management Released- underpinning the requirement for appropriate QRM implementation across the product and project lifecycle.
2024
Digital Twins Enter GMP Design
AI-driven validation and digital twin technologies begin reshaping commissioning and qualification — the next frontier in faster facility delivery.
2025
New Leadership Era
New leadership team, led by CEO Sheena Dempsey, guides CAI into its next phase of growth — investing in people, systems and technology, including deployment of additive digital technologies, right-sizing of the organization and M&A opportunities.
2026
30 Years of Building What’s Next
From Indianapolis to 15+ countries — three decades helping industry deliver medicines and mission critical infrastructure, faster.
VOICES BEHIND THE VISION
“Looking back on the past three decades, I’m incredibly proud of how far our company has come and the role our people have played in supporting the safe, efficient delivery of medicines and critical therapies to patients worldwide. Our growth has always been driven by listening to our clients and anticipating what they’ll need next. As we enter our fourth decade, that commitment is unwavering and guides us to help shape the future of life sciences and mission-critical operations.”
Robert Chew
Founder
“At the heart of our sustained success is our amazing team of experts that continuously support operational readiness and excellence, Through a shared commitment to doing the work right, our employees are empowered to develop solutions, share lessons learned, and continuously raise the bar. That collective expertise is how we deliver consistent results across projects of varying sizes and complexities across the globe.”
Sheena Dempsey
Chief Executive Officer
THIRTY YEARS IN, WE'RE JUST GETTING STARTED.
CAI was built on the belief that operational readiness isn’t a checkbox — it’s a foundation. For every client we’ve partnered with, every system we’ve validated, every readiness milestone we’ve helped achieve, the goal has always been the same: make what’s next possible.