Our Approach

Pharada conducts GMP & GLP gap analyses using a regulatory inspection mindset. We assess systems, behaviors, documentation, and decision-making as an inspector would—focusing on data integrity, governance effectiveness, and operational robustness.

Our reviews are risk-based, evidence-driven, and practical, translating regulatory requirements into prioritized actions that strengthen compliance while supporting business objectives. We align findings with GMP/GLP principles, current inspection trends, and the organization’s maturity level.

The Challenge

Many organizations appear compliant on paper yet face recurring regulatory observations, delayed approvals, or inspection stress due to:

• Fragmented or inconsistently implemented quality systems

• Gaps between documented procedures and actual practices

• Weak data integrity controls and laboratory governance

• Reactive inspection preparation rather than sustained readiness

• CAPA systems that address symptoms, not root causes

Without a clear, risk-based understanding of compliance gaps, organizations remain vulnerable to repeat findings and regulatory escalation.

Delivery Model

Services are delivered through a flexible and blended model, tailored to client needs:

• On-site or remote assessments

• Document-based and operational reviews

• Single-site or multi-site evaluations

• Short diagnostic reviews or full-system gap analyses

What We Deliver

• Clear, structured gap analysis report aligned with GMP/GLP requirements

• Risk-ranked findings with regulatory impact assessment

• Practical, prioritized remediation roadmap

• Executive-level summary highlighting inspection-critical risks

• Actionable recommendations focused on sustainability—not quick fixes

Who This Is For

• Pharmaceutical and life sciences manufacturers

• Quality control and testing laboratories

• Organizations preparing for regulatory inspections

• Companies addressing warning letters or repeat observations

• Management teams seeking objective, third-party compliance insight

Service Scope

Our GMP & GLP Gap Analysis services may include, depending on scope and regulatory context:

• Comprehensive GMP or GLP compliance assessments

• Laboratory and data integrity gap analysis

• Quality Management System (QMS) effectiveness reviews

• Inspection readiness and mock inspection exercises

• Review of SOPs, records, and governance structures

• Risk-based classification of findings (critical, major, other)

• CAPA adequacy and sustainability evaluation