Specialist Assurance Practice
Independent Audit, Assurance & Regulatory Consulting for Regulated Industries
Helping pharmaceutical, biotechnology, medical device and healthcare organisations strengthen compliance, reduce regulatory risk and maintain inspection readiness.
What We Bring
Scope
Any regulatory framework applicable to your operations, GxP, ISO, national and international standards
Reach
EU, UK, US, India and international regulatory requirements across all regulated sectors
Delivery
Onsite, remote or hybrid, scoped to your timeline and geography
Reports
Issued within 10 working days of audit completion
Frameworks & Standards We Work Within
The Compliance Lifecycle
End-to-End Compliance Services
Six integrated practice areas covering every phase of your compliance programme — from initial strategy through to continuous monitoring.
Phase 01 — Strategise
Regulatory Intelligence & Strategy
“Know what regulators expect before they do.”
Build your compliance programme on a foundation of current regulatory intelligence. We map applicable requirements, monitor emerging guidance and translate complex frameworks into actionable strategy — before a submission, inspection or market entry.
Explore Strategise ServicesServices in this phase
Why Sthira Assure
Quality directors and compliance leaders choose us because our assessments reflect genuine regulatory risk, not audit fatigue or commercial pressure.
Independent Assessment
We have no commercial relationship with the suppliers and systems we audit. Our findings reflect genuine regulatory risk, not commercial convenience or client preference.
Risk-Based Methodology
Every audit begins with a structured risk assessment. We focus effort on the areas most likely to affect product quality, patient safety and regulatory standing.
Global Regulatory Expertise
Our team brings experience across EU, UK, US, India and international regulatory frameworks, from EMA and MHRA to FDA, CDSCO, WHO GMP and PIC/S.
Practical Recommendations
Our reports contain actionable recommendations grounded in current regulatory guidance and real-world industry practice, not generic observations.
Technology-Enabled Delivery
Structured processes, consistent audit protocols and modern tools allow us to deliver well-documented, repeatable programmes regardless of site location or scope.
Rapid Mobilisation
When an inspection notification arrives or urgent remediation support is required, response time matters. We mobilise quickly for time-critical engagements, including pre-inspection mock assessments, for-cause audit responses and urgent gap assessments at short notice.
Industries We Serve
Our audit and assurance services are tailored to the regulatory expectations, risk profiles and quality system requirements of each sector.
How We Work
A Structured Audit Methodology
Our methodology is built on a structured, repeatable framework that ensures consistency, thoroughness and regulatory alignment across every engagement, regardless of scope, geography or site type.
View our full methodology →Ready to Strengthen Your Compliance Programme?
Speak with our team about your audit, assurance or regulatory consulting requirements.