Two ecosystems. One discipline.
We work at the intersection of regulation and innovation—where the stakes are patient safety and the pressure is relentless.
Life Sciences
The drug development and manufacturing ecosystem—from discovery through commercialization, navigating FDA, EMA, and global GxP regulations.
Enterprise Pharmaceutical
Global companies like Pfizer, Merck, J&J—Full-scale transformation, embedded consulting, enterprise-wide validation.
Mid-Market Companies
Regional pharma, established biotechs—Strategic guidance with targeted ForgeRx implementation.
Startups & Emerging Biotechs
Pre-commercial, first FDA submissions—Fractional CQO solutions + ForgeRx platform.
Healthcare
The entire healthcare delivery system—being rebuilt around data-driven decisions. Every layer needs decision intelligence frameworks.
Payer Layer
PBMs, insurance, health plans—Decision intelligence for formulary management, prior authorization, value-based care.
R&D Layer
CROs, CDMOs—Quality frameworks bridging clinical development and commercial manufacturing.
Provider & Patient Layers
Health systems, clinics, direct-to-patient platforms—EHR optimization, AI-assisted diagnosis, remote monitoring.
Decision Quality is the discipline both industries forgot to build.
Data Integrity is foundational. But it's not enough.
The harder question isn't "Is the data accurate?"—it's "Who decided, with what evidence, at what risk, and who's accountable when it's wrong?"
That's Decision Quality.
We don't deliver trust. We design the conditions where decisions earn it.
"Data integrity makes data usable. Decision quality determines whether harm occurs."
From awakening to accountability.
ProcellaRX is an ecosystem for reinvention.
THE STANCE
We believe what the industry won't say out loud.
- Eighty percent of your SOPs could be automated. The question is what you're doing with the other 20%.
- AI won't replace Quality. But Quality teams that refuse to learn will replace themselves.
- You cannot document your way to trust. You can only demonstrate your way there.
- Modern capability raises the bar on what 'knowing' means—and what 'responsible action' requires.
"The real barrier to modernization isn't capability. It's the unwillingness to be held accountable for what's possible."
Ready to stop asking for trust and start earning it?
Whether you're rethinking your validation approach, building Decision Quality into your organization, or need fractional quality leadership—let's talk.