Identifying Gaps, Elevating Compliance.

Bridging the Compliance Divide: Why GAP Audits Are Critical

In the ever-evolving pharmaceutical landscape, compliance with global regulatory standards such as WHO, PIC/s, EU GMP, and USFDA is non-negotiable. Non-compliance can lead to significant operational risks, regulatory penalties, and loss of market access.

At Qualifyo, we understand the challenges pharmaceutical companies face in aligning their operations with these stringent requirements. Our GAP Audit service is designed to identify compliance deficiencies, benchmark them against global standards, and provide actionable solutions, ensuring your organization remains inspection-ready.

How We Deliver

Qualifyo’s Methodology

At Qualifyo, we adopt a structured, end-to-end approach for facility design and setup:

01

Customized Audit Design
We engage closely with stakeholders to define audit objectives, understand operational intricacies, and tailor the audit framework to align with specific regulatory contexts.

02

In-Depth On-Site Evaluations
Our expert auditors conduct meticulous evaluations of facilities, systems, and documentation, benchmarking them against global regulatory standards (e.g., WHO, EU GMP, USFDA, PIC/S).

03

Analytical Gap Identification
Leveraging advanced audit tools and robust methodologies, we pinpoint non-conformities, latent risks, and critical gaps in compliance.

04

Comprehensive Reporting
We provide detailed audit reports that prioritize findings by severity and include actionable recommendations for corrective and preventive actions (CAPA).

05

Implementation Guidance
Our team offers hands-on support for implementing CAPA and conducts follow-up assessments to ensure sustained improvements and compliance
Deliverables and Outcomes

What We Deliver

In-Depth Gap Analysis Report

A detailed document outlining compliance gaps, observations, and regulatory risks, accompanied by bespoke recommendations

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Risk Assessment Framework

Categorized findings to prioritize actions based on regulatory impact and operational urgency.

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Compliance Action Plan

A systematic roadmap designed to address identified gaps effectively and within defined timelines.

Best Practice Insights

Comparative analysis and benchmarking against industry standards to elevate operational excellence.

Expert Advisory Access

Ongoing consultation with Qualifyo’s seasoned auditors for implementation and follow-up support.

Why Choose Qualifyo?​

  • Global Competence

    Our multidisciplinary team combines decades of experience in international regulatory compliance, offering unparalleled insights and solutions.

  • Bespoke Solutions

    Each audit is tailored to the client’s unique operational, regulatory, and market-specific requirements.

  • Proactive Risk Mitigation

    We empower clients to identify and address compliance vulnerabilities before they escalate, mitigating potential regulatory or reputational risks.

  • Innovative Methodologies

    Advanced auditing tools and evidence-based techniques ensure precision and actionable results.

  • Trusted Partner

    Recognized by global pharmaceutical leaders for delivering reliable and impactful compliance solutions.

ROI / Benefits for Your Organization

  • Enhanced Regulatory Compliance

    Minimize the risk of enforcement actions, product recalls, or certification denials through early identification of compliance gaps.
  • Strengthened Market Position

    Build trust with regulatory authorities, stakeholders, and customers by demonstrating robust compliance
  • Operational Excellence

    Facilities designed for lean workflows and optimal productivity.
  • Cost Efficiency

    Avoid significant financial losses from penalties, production stoppages, or regulatory delays.
  • Sustainable Success

    Develop a clear, structured pathway toward achieving and maintaining long-term compliance and operational superiority.

Take the Next Step Towards Compliance

Ensure your operations meet global standards with our expert GAP Audit services.

Let’s Discuss Your Compliance Needs

Schedule a one-on-one consulting session with our experts to explore how we can help you bridge compliance gaps.

Ready to Get Started?

Provide your details, and we’ll send you a customized quote for your GAP Audit requirements.