About Kevin K. Williams
28 years in regulatory affairs — and counting.
Global Reach
The space between a solo consultant and a large CRO has always needed filling.
With nearly three decades of operational experience across the US, EMA, South America, Australia, and Africa, Kevin has helped organizations of every size move applications through the regulatory process with confidence — from first-in-human INDs to complex multi-module NDA and BLA programs.
Whether serving as embedded regulatory staff or managing a complete filing program end-to-end, the approach has always been the same: one point of contact, full accountability, and a deliverable you trust enough to submit — and come back for the next one.
KKW Regulatory Solutions was founded to fill the space between the solo consultant with limited bandwidth and the large CRO that hands your project off to a junior team. Boutique scale. Senior expertise. No overhead.
US FDA
EMA (Europe)
South America
Australia (TGA)
Africa
28
Years of experience
5+
Regulatory regions
8
Core service areas
What Sets KKW Apart
Built differently, by design.
One point of contact
You speak to the same person who does the work. No hand-offs, no junior substitutes, no account manager layer.
Senior expertise, always
28 years of hands-on submissions experience, not advisory opinions. Every deliverable reflects direct operational knowledge.
Global, without the overhead
Multi-jurisdiction experience across five regulatory regions — without the infrastructure costs of a global CRO.
Built around your program
Engagements are scoped to what you actually need — hourly, retainer, or full program management. No minimum footprint required.