GMP Solutions and Inspection Readiness

Ensuring full regulatory compliance, assured quality, and total peace of mind during critical regulatory audits.

Our Role

We combine deep knowledge with hands-on experience in pharmaceutical and chemical plants to ensure processes, quality systems, and documentation to rigorously comply with GMP and regulatory standards.

Facility Readiness

  • Facility preparation for FDA, EMA, and local regulatory authority inspections.

  • Strategic coaching and mock audits directed at technical teams.

GMP Remediation

  • Rapid compliance gap diagnostics and design of corrective action plans.

  • High-level support for critical out-of-specification (OOS) results.

Quality systems

  • Building robust, inspection-ready Quality Management Systems (QMS).

  • Ensuring protocol reproducibility and strict adherence to data integrity under ALCOA+ regulations.

Regulatory Strategy

  • Leadership in Process Performance Qualification (PPQ) for global filings.

  • Chemistry, Manufacturing, and Controls (CMC) assurance for regulatory dossiers.

Representative engagements

    • Technical Action: Design of a Six Sigma-based investigation framework. Implementation of a Systematic Root Cause Analysis (RCA) using the Ishikawa (5M) diagram.

    • Strategic Impact: Dramatic reduction in recurring deviations. Establishment of a "First-Time-Right" culture.

    • Technical Action: Re-evaluation of process limits. Formal reclassification of pH as a Critical Process Parameter in the validation master plan.

    • Strategic Impact: Enhancement of process robustness.

    • Technical Action: Drafting of the corporate Standard Operating Procedure (SOP) and design of risk analysis records and templates (ICH Q9).

    • Strategic Impact: Successful application for the reclassification of critical reagents as CPPs.

    • Technical Action: Execution of the newly designed risk assessment protocol for the reclassification of reagent dosage as a Critical Process Parameter (CPP).

    • Strategic Impact: Assurance of process robustness and high-quality reproducibility.

Let’s talk about your next inspection

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