Pharma GxP is a compliance and validation advisory focused on helping pharmaceutical, biotech, and medical device organizations build regulatory compliance into their systems from the design stage.

Founded by Saket Yeotikar, a Chemical Engineer and GxP Compliance Strategist with over 12 years of industry experience, Pharma GxP brings practical expertise across manufacturing, automation, and digital system validation. The focus is on implementing risk-based, inspection-ready frameworks aligned with global regulatory expectations.

Our work spans Computer System Validation (CSV), process and cleaning validation, quality risk management, and digital compliance under regulations such as 21 CFR Part 11, EU Annex 11, and GAMP 5. We support organizations in designing validation lifecycle strategies, strengthening data integrity controls, and preparing systems for successful regulatory inspections.

By combining shop-floor experience with compliance strategy, Pharma GxP helps organizations simplify complex regulatory requirements and build lean, efficient, and audit-ready systems.

Based in India and working globally, Pharma GxP collaborates with pharma manufacturers, biotech companies, and medical device organizations to ensure compliance supports real quality, operational efficiency, and faster product release.

Pharma GxP

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Pharma GxP

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