Program & Project Management
Capital Project Delivery Aligned with Operational Goals
Executing a capital project in pharmaceutical manufacturing means managing more than just budget and schedule—it means orchestrating people, systems, compliance, and business risk with precision. Agile Advisors delivers program and project management services that prioritize cGMP readiness and startup success from the first planning session through to facility handover.
We don't just coordinate workstreams—we lead projects with owner-side insight, helping our clients translate investment into production outcomes that hold up under regulatory scrutiny.
What We Deliver
Front-End Planning & Governance
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Capital planning and FEL strategies that align with long-term production goals
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Scope definition frameworks and business case clarity
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Governance models that support fast, aligned decision-making
Compliance-Integrated Delivery
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Milestones synced with validation, quality, and documentation needs
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Readiness integration for CQV, training, and SOP development
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Management of turnover strategy from mechanical completion to commercial run
Execution Management
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Integrated schedules with critical path tracking and issue escalation
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Cost control, risk registers, and resource performance tracking
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Coordination across EPCM firms, OEMs, construction, and validation teams
Program Oversight
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Portfolio-level visibility and prioritization across multiple capital investments
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KPI-driven dashboards and standardized project reporting
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Alignment with global CapEx governance and audit readiness standards
Why It Matters
Projects that hit their milestones but miss regulatory readiness dates don’t succeed. Our approach keeps execution grounded in your operational objectives—whether you’re building new sterile fill/finish capacity or retrofitting a biologics line under live operations.
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Agile Advisors has led integrated programs for multi-phase pharmaceutical builds ranging from $30M to $380M, acting as the connective tissue between funding decisions, vendor execution, and QA compliance.
We don’t just manage capital plans—we deliver production-ready facilities with nothing left on the table.
Ideal Project Types
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New production facilities, line expansions, and facility retrofits
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High-complexity environments with utilities, automation, and cleanroom scopes
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Projects requiring validation, startup, and tech transfer coordination
