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Capital Project Execution for GMP-Regulated Environments 

We support life science manufacturers facing high-stakes capital projects. Whether you’re building new capacity, expanding sterile production, or recovering a troubled program, Agile Advisors delivers services that keep compliance, cost, and operational readiness aligned.

Each service offering is structured to be delivered independently or as part of an integrated engagement—depending on your internal resources, project state, and delivery risk. 

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Program & Project Management

Full-scope capital program execution aligned with your facility’s production goals. Includes planning, scheduling, controls, and vendor coordination. 

Owner's Program Manager

Independent oversight embedded within your team. We manage vendors, contracts, and delivery risk with a focus on GMP and business outcomes. 

cGMP Compliance & Operational Readiness

cGMP strategy built into capital project delivery. We prepare teams, systems, and facilities for audit, inspection, and commercial production. 

Project Recovery & Risk Mitigation

Stabilization support when capital projects fall behind or fall apart. We identify root causes, realign execution, and protect critical timelines. 

CQV Leadership

Commissioning, Qualification, and Validation support built for inspection readiness. We integrate QA, engineering, and documentation from the start. 

Fractional Leadership & Mentorship

Senior-level experts embedded directly in your project structure—supporting strategy, decision-making, and execution continuity. 

What Our Clients Say

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Global Expansion Program - Owner's Project Management (Large Pharma)

"Agile Advisors brought structure and clarity to a highly complex facility expansion. Their team coordinated across design, construction, CQV, and compliance stakeholders while always keeping our project goals front and center. They understood the nuances of regulated environments and consistently advocated for what was best for our operation. Their presence raised the bar for the entire program." 
-Director, Global Engineering

Need Help Choosing the Right Service Mix? 

If you’re not sure where to start, we’ll guide you based on your project phase, internal capacity, and delivery risk. 

Contact Agile Advisors to schedule a conversation. 

 

Let me know if you’d like this page to include visual blocks or anchor-link navigation for long-scroll layouts. Otherwise, your entire web structure is now complete and fully aligned with Agile’s strategic positioning. 

CONTACT
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Ready to Talk?

We work with decision-makers who need execution certainty, regulatory alignment, and leadership in the field. 

332 Golf View Drive
Greenville, NC 27834
 

Tel: 252-531-7713
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