Processes live in people's heads
When the one person who knows how it works is out, everything slows down or goes wrong.
Quality · Compliance & Audits · Operations · Workforce · Business Support
Build a stronger foundation for your business
We help owners and leaders put clear processes, inspection-ready systems, and stronger teams in place, using proven methods sized for the way your business runs.
- Inspection-ready quality systems
- Compliance remediation that sticks
- Trained, confident teams
YOUR BUSINESS
Stronger teams
Effective systems
Clear processes
01Quality
02Compliance & Audits
03Operations
04Workforce
05Business Support
Sound familiar?
Growth gets harder when the foundation is shaky
An inspection or audit is coming
You're not sure your records, policies, and training would hold up if someone walked in tomorrow.
Growth is outpacing your team
New hires, new locations, new rules. The way you've always done it no longer keeps up.
Our services
Five foundations, built together
Choose one area or build all five. Every engagement ends with finished work your team can use: systems, documents, dashboards, and trained people.
Quality
A quality system that catches problems before your clients or regulators do, and fixes them so they stay fixed.
EXPERIENCE BEHIND IT
Our leadership has performed and led internal, supplier, client, and regulatory audits, and closed 4,000 open corrective actions in six months.
- Quality Management System built for your size and industry
- Document control and SOP libraries
- Incident, complaint, and deviation management
- Root cause analysis: 5 Whys and Fishbone
- Corrective and preventive action (CAPA) plans
- Effectiveness checks that prove the fix worked
- Quality audits and audit readiness
- Quality metrics, trending, and reporting
Proven results
The experience behind our work
Results our leadership has delivered inside pharmaceutical, biologics, plasma, and clinical research organizations, now applied to businesses of every size.
- years in quality, compliance & operations
- 20+years in quality, compliance & operations
- FDA/MHRA regulated sites led to 100% inspection readiness
- 25+FDA/MHRA regulated sites led to 100% inspection readiness
- corrective actions closed in six months
- 4,000+corrective actions closed in six months
- FDA Form 483 observations on inspections hosted
- 0FDA Form 483 observations on inspections hosted
Our approach
Assess. Build. Sustain.
A structured, proven path from where your organization is today to consistent, compliant, and scalable operations.
- 1
Assess
We learn how your business really runs through a gap assessment, audit, and conversations with your team, then rank what needs attention first.
- 2
Build
We put the fixes in place: processes, SOPs, handbooks, dashboards, and training, built alongside your people so they own it.
- 3
Sustain
We track results, coach your leaders, and check back to make sure the improvements hold as you grow.
Why Foundation Five
Built for businesses that need the work done, not just advice
Hands-on, not just advice
You get finished SOPs, dashboards, handbooks, and trained staff, not a slide deck.
Big-company rigor, sized for you
Proven systems from demanding industries, scaled to your size and budget.
A true collaboration
We work side by side with your team across all five areas, so the solutions fit your business and your people own them.
Certified methods
Lean Six Sigma Black Belt, ISO 19011 Lead Auditor, and ISO 37301 Compliance Management Systems.
Who we serve
Built for businesses ready to grow
Healthcare & behavioral health
Clinics, practices, and agencies that answer to licensing boards, payers, and HIPAA.
Medicaid waiver & HCBS
Home and community-based providers preparing for surveys and documentation reviews.
Clinical research & life sciences
Sites, sponsors, and partners working under GCP, GMP, and FDA expectations.
Small & growing businesses
Owners ready to trade daily firefighting for systems that run without them.
About us
Senior expertise, small-business attention
Lean Six Sigma Black BeltISO 19011 Lead AuditorISO 37301 Compliance ManagementGCP ICH E6
Foundation Five Consulting was built on a simple idea: every business deserves clear processes, dependable systems, and a team set up to succeed, whether you're a five-person startup or a multi-location organization.
Our approach draws on more than 20 years of experience across healthcare, life sciences, and growing businesses, including some of the most demanding regulated environments there are. We work alongside your team, remotely nationwide, with on-site support available when your project calls for it, to build practical systems that fit your business and last as you grow.
Questions
Good to know
Careers
Grow with Foundation Five
We're building a team of practical, people-first professionals in quality, compliance, operations, and workforce development.
No open positions right now
If you share our commitment to doing the work right, we'd still like to hear from you.
Send Us Your ResumeGet started
Ready to build a stronger foundation?
Schedule a free consultation. Tell us a little about your business and we'll be in touch to find a time to talk.
- info@foundationfiveconsulting.com
- +1 (352) 744-9487
- Remote nationwide · On-site available