Singapore · GxP QA · Global Reach

GxP Excellence.
Integrity in
every step.

Sparsh Strategic Consulting helps pharmaceutical, biotech, and medtech organisations achieve compliance, quality, and regulatory readiness, backed by 25+ years of global experience.

GCP · GMP · GVP · GLP FDA · EMA · MHRA · PMDA Clinical Development Singapore-based
25+
Years of global GxP industry experience
1,000+
GxP audits performed across all major domains
12
Health authorities: FDA, EMA, PMDA, TGA, MHRA, Health Canada, Anvisa and more
Sectors served
Pharmaceuticals Biotechnology Medtech & Wearables Contract Research Organisations Site Management Organisations Academic Research Institutions
When clients call us
Senior, independent quality judgement.
When routine process is not enough.

Clients typically call Sparsh when they need experienced, independent GxP quality judgement on matters that cannot be handled through internal process alone.

Inspection approaching
A regulatory inspection is imminent and the organisation needs practical, experienced readiness support, not just a checklist.
Repeat or significant findings
An audit has identified significant or recurring findings and the team needs help separating symptoms from root causes before the next inspection.
Serious breach or major deviation
A serious breach, major deviation, or critical quality event requires structured, independent assessment and defensible decision-making support.
Independent vendor or CRO oversight
Vendor oversight, clinical operations, pharmacovigilance, or study-level quality risks need independent, experienced review outside the sponsor organisation.
Quality system learning, or not learning
Leadership wants an honest, independent view of whether their quality system is genuinely learning from past issues, or simply closing CAPAs and repeating the same findings cycle after cycle.
Talk to Sachin →
What we do
Our Services

End-to-end GxP QA consulting, auditing, training, and strategic advisory for life sciences organisations worldwide.

GxP Audits & Inspection Readiness

Global GxP Audits & Compliance

Investigator site, pharmacovigilance, CSV, GDP, and for-cause audits. For sponsors, CROs, vendors, and clinical trial service providers.

Regulatory Inspections

Mock inspections, readiness assessments, and post-inspection response for FDA, EMA, MHRA, PMDA, NMPA, MFDS, and TFDA.

Training & Education

GCP training, inspection readiness, data integrity programmes, and CAPA implementation workshops tailored to your team.

Quality Risk Management & Serious Non-Compliance

Quality & Risk Management

Complex quality events, repeat findings, serious breaches, major deviations, RCA/CAPA review, and quality governance support.

GxP Consultancy Services

GCP, GVP, GLP, GMP, CSV, GDP: QMS development, optimisation, vendor qualification, and strategic compliance advisory.

New Tech & Clinical Development

SaMD, digital health, and wearables quality integration. End-to-end clinical development strategy with a holistic patient safety perspective.

Who we serve
Industries

Tailored solutions across the life sciences spectrum, from multinational pharma to academic research institutions.

Pharmaceuticals Biotechnology Medtech & Wearables Contract Research Organisations Site Management Organisations Academic Research Institutions
About
Founded on expertise. Built on integrity.

Sparsh Strategic Consulting was founded by Sachin Pasumamula, a GxP quality assurance professional with over 25 years of experience across pharmaceutical, biotech, medtech, and clinical development organisations on five continents.

SP
Sachin Pasumamula
Founder & CEO
LinkedIn

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, for which a patent was filed in Singapore in April 2026.

His approach combines deep regulatory knowledge with a genuine belief that quality is not a compliance exercise. It is the foundation of patient safety.

25+
Years of global GxP industry experience
1,000+
Audits performed across all GxP domains
30+
Countries across 5 continents
7
Health authorities: FDA, EMA, PMDA, TGA, NMPA, MFDS, DCGI
Introducing our platform

Meet SQIP: Sparsh Quality
Intelligence Platform

SQIP is being developed to help organisations strengthen the reasoning behind quality decisions, with the long-term goal of reducing repeat findings through better root cause analysis, CAPA logic, and organisational learning.

Patent Filed · Singapore · April 2026 · PCT Filing in Progress

Explore SQIP →
Live
SQIP RCA
Live
SQIP Inspect
Live
SQIP CAPA
Building
SQIP Risk
Building
SQIP Assist
Roadmap
SQIP Memory
Roadmap
SQIP Oversight
Roadmap
SQIP Vendor
Get in touch
Let's talk

Ready to elevate your GxP compliance posture? Drop us a message and a Sparsh principal will respond within 24 hours.