About Us

Who We Are

QualyInc is a specialized GMP consulting firm dedicated to serving the pharmaceutical, biologics, medical device, and diagnostics industries. We provide expert guidance across the entire GxP lifecycle, helping companies achieve and maintain global regulatory compliance. Our focus is on delivering customized, actionable strategies and execution support to meet complex regulatory demands?anywhere in the world.

Our Expertise

We are successfully addressed a wide range of challenges across all stages of the GxP lifecycle, applying deep technical knowledge and real-world industry insights. Our consulting services include:

    GMP Gap Analysis

    Audit Readiness Preparation

    Audit Response and Remediation

    Regulatory Compliance Strategy

    Quality System Development and Strengthening

    Process Validation & Documentation Support

    Staff Training & Inspection Readiness

We tailor each engagement to the client's specific requirements, ensuring practical solutions with measurable outcomes.



Our Mission


To be a trusted partner for companies striving to deliver safe, effective, and compliant products to global markets—through quality, integrity, and compliance.

Our Vision

To empower businesses worldwide by setting the standard for excellence in quality, compliance, and safety, driving innovation and fostering trust in global markets.
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