Sparsh supports life sciences organizations when quality risk, regulatory readiness, or repeat findings require independent senior judgment.
Clients typically call Sparsh when they need experienced, independent GxP quality judgment on matters that cannot be handled through internal process alone.
Practical readiness support when a regulatory inspection is imminent and a checklist is not enough.
Support separating symptoms from root causes before the same issue returns in the next audit or inspection.
Structured, independent assessment and defensible decision support for critical quality events.
Experienced review of vendor oversight, clinical operations, pharmacovigilance, and study-level risks.
An honest view of whether your quality system is learning from past issues or simply closing CAPAs.
Sparsh is built around the quality situations where senior judgment, regulatory experience, and practical execution matter most.
Independent GxP audits, mock inspections, readiness reviews, and inspection response support for sponsors, CROs, vendors, and clinical trial service providers.
Senior advisory support for complex quality events, repeat findings, serious breaches, major deviations, RCA/CAPA review, and quality governance.
Advisory and platform-led support for teams exploring how structured reasoning, AI, and quality intelligence can strengthen RCA, CAPA, and inspection readiness.
Sparsh Strategic Consulting was founded by Sachin Pasumamula, a GxP quality assurance professional with more than 25 years of experience across pharmaceutical, biotech, medtech, and clinical development organizations.
Sachin has conducted and overseen GxP quality assurance engagements across 30+ countries and 5 continents, working directly with 12 health authorities including the FDA, EMA, PMDA, TGA, MHRA, NMPA, MFDS, Taiwan FDA, DCGI, HSA, Health Canada, and Anvisa.
He is the author of Quiet Watchdogs: GxP Quality Assurance, The Unsung Heroes Safeguarding Integrity Across the Drug Development Lifecycle, currently under publication, and the founder of SQIP, the Sparsh Quality Intelligence Platform.
Sparsh is building a global collaboration model with experienced GxP QA consultancies and regionally based auditors, allowing clients to access broader audit and inspection readiness support while retaining senior, founder-led quality oversight.
Countries across 5 continents
Health authorities engaged across global work
Years of global industry experience
Audits personally conducted or led, with broader audit oversight across major GxP domains
SQIP is being developed to help organizations strengthen the reasoning behind quality decisions, with the long-term goal of reducing repeat findings through better root cause analysis, CAPA logic, and organizational learning.
Patent Filed · Singapore · April 2026 · PCT Filing in Progress
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