Supplier Qualification Audits

Strengthening Pharmaceutical Supply Chains Worldwide.

Ensuring Quality from the Source

In the complex pharmaceutical landscape, maintaining a robust and compliant supply chain is crucial. Supplier Qualification Audits are an essential part of managing risks, ensuring quality, and complying with regulatory expectations.

At Qualifyo, we specialize in empowering pharmaceutical organizations to meet these demands through meticulous supplier evaluations. With a global reach, local expertise, and a proven track record, Qualifyo delivers unparalleled audit services tailored to your needs.

How We Deliver

How Qualifyo Delivers This Service

At Qualifyo, we adopt a comprehensive, end-to-end approach to ensure supplier compliance

01

Pre-Audit Planning

We work with you to define the audit scope, standards and specific objectives

02

On-Site Audits

Our expert auditors evaluate supplier facilities against regulatory standards, focusing on GMP compliance, data integrity, and operational risks.

03

Comprehensive Documentation

Post-audit, we provide detailed audit report (within 5 working days), CAPA (Corrective and Preventive Action) plans, and closure documentation.

04

Follow-Up Support

Our team ensures suppliers close gaps effectively and align with compliance requirements.

What We Provide?

Audit Report Package

Including a detailed audit report, CAPA Compliance Report, Auditor CVs, Non-Conflict of Interest Statement, and Closure Letter.

Comprehensive Regulatory Coverage

Adhering to EudraLex Vol. 4 Part II, ICH Q7, ISO standards and many other standards.

Global Expertise

Conducting audits in key hubs like India, China, Europe, US, and Latin America, with experienced local auditors.

Why Choose Qualifyo?

Seasoned Auditors

Our auditors have completed over 150+ supplier site audits individually and are qualified under our rigorous GxP Auditor Qualification Program.
Unparalleled Experience

We have conducted over 700+ audits for pharmaceutical organizations worldwide, with reports reviewed and accepted by regulatory agencies.
Independent and Unbiased Evaluations

Our audits deliver impartial assessments, ensuring transparency and compliance.
Speed and Efficiency

Audit reports delivered within 5 working days, minimizing operational disruptions.
Global Reach and Local Expertise

With qualified auditors in major manufacturing hubs, we bridge global regulatory requirements with local insights.

ROI and Benefits for Clients

Reduced Supply Chain Risks

Identify and mitigate potential compliance and operational issues proactively.
Regulatory Credibility

Enhance trust and confidence with regulatory agencies through meticulous audit documentation.
Cost-Effective Compliance

Streamline supplier qualification processes, saving time and resources.
Enhanced Supplier Relationships

Strengthen partnerships with suppliers through structured evaluations and follow-ups.
Global Coverage

Leverage a network of qualified auditors in 25+ countries to ensure worldwide compliance.