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.