Comprehensive Audit Services –
Ensuring Quality, Compliance & Confidence

Ensuring Compliance, Mitigating Risks:
Why Audits Matter ​

In the highly regulated pharmaceutical industry, compliance with global standards is critical to ensuring the safety, efficacy, and quality of products. Regulatory audits play a vital role in identifying gaps, mitigating risks, and safeguarding organizations from potential penalties or reputational damage. Qualifyo’s specialized Audit Services are designed to proactively address these challenges by offering thorough gap analyses, aligning operations with current regulatory frameworks, and fostering a culture of continuous improvement. Our audits cover critical areas such as cGMP, GDP, and GLP compliance, helping organizations achieve excellence while maintaining patient trust.

HOW IT WORKS

How Qualifyo Delivers Exceptional Audit Services​

At Qualifyo, we approach audits with a meticulous, risk-based mindset. Our team of seasoned experts leverages decades of experience and an in-depth understanding of global regulatory standards like WHO, PIC/S, EU GMP, and USFDA. We conduct audits with precision, offering actionable insights and practical recommendations that enable organizations to strengthen their compliance frameworks.

Our methodology includes:

01

Preparation & Planning
Tailored audit scopes based on your needs.

02

Execution
Detailed site inspections, documentation reviews, and personnel interviews.

03

Reporting
Comprehensive, easy-to-understand audit reports with risk categorization and improvement strategies.

04

Post-Audit Support
Guidance for corrective and preventive actions (CAPA).

What Qualifyo Offers in Audit Services

Validate and qualify your suppliers to ensure reliable and compliant partnerships.

Identify compliance gaps with standards such as WHO, PIC/s, EU GMP, and USFDA.

Simulate regulatory inspections to prepare your facilities for real-world audits.

Safeguard your critical data with specialized integrity audits.

Assess potential risks and compliance of acquisitions or partnerships.

Rapid, thorough investigations to identify root causes of compliance concerns.

Benefits of Working with Qualifyo

  • Proactive Compliance

    Stay ahead of evolving regulatory requirements.
  • Risk Mitigation

    Minimize potential penalties and reputational damage.
  • Operational Efficiency

    Identify and rectify inefficiencies in processes.
  • Business Growth

    Gain a competitive edge with robust compliance systems.
  • Peace of Mind

    Confidently navigate inspections with preparedness and support.

Why Choose Qualifyo?​

  • Global Expertise

    With over 20 years of experience and collaborations with experts worldwide, we bring unparalleled regulatory knowledge.

  • Customized Solutions

    Tailored audit frameworks for each client, ensuring precision and relevance.

  • Proven Track Record

    Trusted by pharmaceutical giants across continents.

  • End-to-End Support

    From planning to post-audit corrective actions, we’re with you at every step.

Audit Testimonials:

Voices of Trust, Stories of Satisfaction

Unlock Your Path to Compliance & Success

Streamline compliance, improve quality, and achieve market excellence with Qualifyo’s tailored services

Start with an Expert Consultation

Discuss your compliance challenges with our industry experts.

Get a Tailored Audit
Plan

Share your requirements, and we will provide a customized audit strategy.

Optimize Your Quality Systems

Let us help you build, upgrade, or validate your QMS efficiently and effectively

Simplify Regulatory Submissions

Provide your project details, and we’ll create a seamless regulatory roadmap.