Qualimaxconsultants

Our Core Audit Services

We help pharmaceutical and life science companies achieve regulatory excellence through strategic, insightful, and value-driven audits.

1. Internal Quality Management System (QMS) Audits

Comprehensive review of procedures, records, and process controls.
Assessment of compliance with cGMP, ISO, and corporate quality standards.
Identification of non-conformities and opportunities for continual improvement.
Action-oriented audit reports for faster CAPA implementation.

2. Supplier & Contract Manufacturer Audits

Qualification and performance evaluation of vendors and CMOs.
Verification of GMP compliance, traceability, and documentation practices.
Audit scoring system to support supplier risk ranking and approval decisions.
Post-audit support to ensure CAPA closure and ongoing compliance.

3. Gap Analysis & Compliance Review

Systematic evaluation of existing QMS against regulatory requirements (FDA, EMA, WHO).
Root cause identification of gaps and inefficiencies.
Tailored CAPA recommendations to strengthen compliance maturity.
Baseline report to prepare for inspections or certifications.

4. Inspection Readiness & Mock Audits

Simulated inspections following FDA/EMA audit methodology.
Preparation of teams and documentation for real audit scenarios.
Feedback sessions to enhance audit communication and confidence.
Action plan to resolve pre-inspection gaps efficiently.

5. CAPA Verification & Effectiveness Review

Verification that CAPA actions are effectively implemented and sustainable.
Tracking closure timelines and documenting evidence of compliance.
Trend analysis to prevent recurrence of similar issues.
Supports continuous improvement and regulatory confidence.

6. Specialized Audits (GCP, GLP, GPV, CSV)

Audits focused on clinical, laboratory, pharmacovigilance, and computerized systems.
Ensures integrity, traceability, and compliance across specialized functions.
Supports readiness for global health authority inspections.
Delivered by domain experts with hands-on pharma experience.

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