cGMP Compliance & Operational Readiness
Compliance Integration Built for Operational Success
Every capital project in a regulated manufacturing environment must be built to support one outcome: operational readiness. Agile Advisors aligns cGMP requirements with business and technical objectives from day one—ensuring your facility is built not just to spec, but for sustained production.
We embed compliance expertise throughout the project lifecycle, working across disciplines to identify risks early, eliminate rework, and deliver facilities that are inspection-ready, audit-ready, and fully aligned with regulatory expectations.
What We Deliver
cGMP Compliance Strategy
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Front-end assessments of facility concepts and layouts for cGMP risks
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Mapping GMP-critical workflows (people, materials, waste, product)
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Cleanroom zoning and classification aligned to ISO, EU Annex 1, and cGMP guidance
Operational Readiness Planning
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Startup readiness assessments integrated with project commissioning
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SOP, training, and deviation protocol planning tied to turnover milestones
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Alignment of tech transfer and validation with construction closeout
Compliance-First Design Integration
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Engineering design reviews against FDA, EMA, and ICH expectations
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Qualification strategy embedded into capital milestones
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Risk-based documentation planning (URS, DQ, FAT/SAT strategy)
Regulatory Engagement Support
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PAI readiness walkthroughs and gap closure planning
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Mock audits with quality and engineering leadership
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Structured response planning for inspection findings
Why It Matters
Capital projects that defer compliance considerations often face post-construction delays, costly retrofits, and approval risks. Agile Advisors eliminates that uncertainty by treating cGMP as a design and execution constraint—not a checkbox at the end. We've helped clients prepare new production facilities and sterile fill/finish expansions valued at over $100M for successful validation and startup.
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Agile doesn’t just manage compliance—we deliver production-ready outcomes that withstand regulatory scrutiny.
Ideal Project Types
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Greenfield and brownfield pharmaceutical manufacturing
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Oral solid dose, sterile, biotech, and ATMP facilities
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New facility builds and major process/utility retrofits
