At Forza Pharma Consulting, we provide comprehensive Commissioning, Qualification, and Validation (CQV) services for life science facilities, utilities, and equipment. Our team brings strong engineering expertise to streamline CQV projects, with extensive experience applying risk-based verification methods in practical, real-world settings. Our approach ensures all key elements for compliance, system sustainability, and local site integration are taken into consideration. Our project strategy ensures effective project team dynamics catered to project needs with strict adherence to schedule.
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Forza Pharma Consulting delivers full-scope Computer System Validation (CSV) services to ensure that GxP-regulated software and automated systems meet compliance and performance standards. We help clients achieve FDA 21 CFR Part 11 and EU Annex 11 compliance while optimizing data integrity and business continuity.
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We provide structured Deviation Investigation (DI) services to identify root causes, implement corrective actions, and prevent recurrence. Our expertise ensures investigations are compliant, thorough, and efficient—reducing downtime and regulatory risk. We excel in recurring cases and complex cases with multiple root causes. And we have experience successfully defending our cases with auditors from the FDA and other regulatory agencies.
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We specialize in Cleaning Validation (CV) programs designed to ensure patient safety, product quality, and regulatory compliance. Our team provides proven strategies for cleaning validation/verification, cycle development, and lifecycle maintenance.
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Forza Pharma Consulting supports clients at all stages of Process Validation (PV) through current risk-based approaches as part of a complete product lifecycle, ensuring processes are designed, qualified, and controlled to consistently produce robust products that meet regulatory expectations of safety, quality, identity, purity, and potency.
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Forza Pharma Consulting supports clients through all stages of Technology Transfer (TT), ensuring both on-time and right-first-time production of comparable product at their receiving sites. Our team has refined and proven our practices over multiple successful tech transfers throughout the different product lifecycle stages (Development to Clinical, Clinical to Commercial, Commercial to Commercial) with involvement as early as receiving site assessment and selection all the way through regulatory filing authorship and site licensure inspection and approval.
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Forza Pharma Consulting provides comprehensive Audit Support (AS) services to help clients prepare for, manage, and respond to regulatory inspections and third-party audits.
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Our Project Management (PM) services ensure life sciences projects are delivered on time, on budget, and in full compliance. We combine industry knowledge with project leadership to drive execution and stakeholder alignment.
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Forza Pharma Consulting provides comprehensive Quality Assurance (QA) services to ensure compliance, consistency, and control across all phases of pharmaceutical and biopharmaceutical operations. Our QA professionals bring deep experience supporting GMP-regulated environments and external manufacturing networks, ensuring alignment with global regulatory requirements and Quality Agreements.
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