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25+ Years in Pharma, Biotech & Digital Health
I work with regulated life sciences organizations to design, build, and govern compliant digital systems — without slowing delivery or innovation.
My work spans technology strategy, system delivery, software assurance, and regulatory compliance under FDA, Health Canada, and EMA oversight.
Operating from Toronto, I provide independent consulting with the agility of a specialist and the execution strength of a seasoned executive — delivering the right balance of speed, rigor, and compliance.
What I Bring
🔍 Right-Sized Delivery: Define and execute digital programs that balance validation rigor with business reality — delivering compliant systems across clinical, laboratory, and operational domains, on time, on budget, and fit for purpose.
🎯 Faster, Risk-Based Validation: Implement Computer Software Assurance (CSA) that eliminates documentation bloat and focuses effort on real patient and product risk.
⚖️ Zero-Surprise Inspections: Build data-integrity controls and audit-ready systems that stand up to FDA, Health Canada, and EMA scrutiny without last-minute remediation.
🧭 Strategic Roadmaps: Bridge IT, QA, and business priorities into executable plans that enable compliant automation without organizational churn.
Select Engagements
GxP System Delivery
Led large-scale implementations with traceability, controlled release, and audit readiness.
Data Integrity Remediation
Resolved critical findings for organizations facing serious regulatory exposure.
CSV-to-CSA Transformation
Cut validation cycles 40–60% using risk-based CSA over document-heavy CSV.
Cloud Migration for GxP
Modernized regulated infrastructure while maintaining continuous compliance.
AI/ML Validation
Enabled regulated AI/ML deployment with practical validation frameworks.
Digital Health / SaMD
Guided digital health products from design through regulatory approval.
Let’s Talk
Facing a regulatory audit? Planning a digital transformation? Addressing validation backlogs or data integrity findings? Bringing medical device software (SaMD) to the US or EU market?
I'd love to hear from you.
Kunal S.
Founder & Principal Consultant
📩 hello@onspeq.ca
📞 +1 (647) 865-4783
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