About
About Sthira Assure
Sthira Assure is a specialist audit, assurance and regulatory consulting practice serving pharmaceutical, biotechnology, medical device and healthcare organisations operating in regulated environments.
Our Mission
Our mission is to provide the life sciences industry with independent audit intelligence that drives genuine compliance improvement, not regulatory checkbox adherence. We believe that compliance should be a genuine operational strength that protects product quality and patient safety, not a burden managed at arm's length through documentation alone.
Every audit Sthira Assure conducts is designed to leave an organisation better equipped to sustain compliance independently. We provide findings and recommendations that build internal capability, not perpetual dependency on external audit support.
Our Vision
We want to be the firm that quality and regulatory leaders turn to when the stakes are highest: before a critical inspection, following a regulatory observation, or when building a compliance programme that needs to hold up under scrutiny.
Our ambition is not to be the largest assurance practice, but to be the most trusted one. That means maintaining the independence, depth of expertise and quality of output that makes our assessments genuinely useful, and never allowing commercial growth to dilute the standards our clients rely on.
In the long term, we aim to raise the standard of independent audit and assurance across the life sciences sector by demonstrating that rigorous, evidence-based assessment and practical, actionable guidance are not in tension but are in fact the same thing.
Who We Work With
Our clients are pharmaceutical companies, biotechnology organisations, medical device manufacturers, contract development and manufacturing organisations, contract research organisations, wholesale distributors and the private equity and corporate teams that invest in and acquire these businesses.
Within those organisations, we work with the leaders who carry direct accountability for quality and compliance, QPs, RPs, quality directors, compliance managers and regulatory affairs professionals who need independent assessment that reflects genuine regulatory expectations rather than commercially convenient findings.
We work with organisations across the EU, UK, US, India and internationally, from early-stage biotechnology companies building quality infrastructure for the first time to established multinationals managing complex global audit programmes.
Typical Roles We Support
- VP Quality & Head of Quality
- Quality Directors and Managers
- Qualified Persons (QPs) and Responsible Persons (RPs)
- Regulatory Affairs Directors
- Compliance and Quality Assurance Leaders
- Clinical Quality Directors
- Supplier Quality Leaders
Our Values
Independence
We have no commercial relationship with the suppliers and systems we audit. Our assessments reflect observed evidence evaluated against regulatory requirements, not commercial pressure or client preference. Our independence is our most important asset and is never compromised.
Precision
Regulatory compliance depends on the quality of evidence gathered and the accuracy of its assessment. We bring analytical rigour to every engagement, findings are evidence-based, specifically referenced and described with the precision that enables effective remediation.
Expertise
We are domain specialists, not generalists. Our auditors have direct operational experience in the regulatory disciplines they audit, GMP, GCP, GDP, GLP, GVP, data integrity, medical devices. We do not assess what we do not understand deeply.
Integrity
We report what we find. Difficult findings are communicated clearly and with evidence. We do not moderate findings to manage client relationships. Organisations that want a genuine independent assessment choose us because they know they will receive one.
Practicality
Regulatory expertise without practical context produces findings that organisations cannot act on. Our recommendations are grounded in both regulatory requirements and industry practice, actionable within real operational constraints, not idealistic prescriptions divorced from implementation reality.
Accountability
We stand behind every audit report we issue. Each finding is supported by specific evidence, assigned a regulatory reference and accompanied by clear remediation guidance. We are available to discuss our reports and support organisations through the remediation process.
Industry Experience
Our team brings direct operational experience across the regulated life sciences sector. We have worked within pharmaceutical quality systems, managed clinical quality assurance programmes and navigated regulatory inspection processes, both as audited and as auditors. This operational background is what enables us to assess quality systems with the depth and nuance that regulatory inspection requires.
We bring experience of GMP, GCP, GDP, GLP, GVP, data integrity, computer system validation and medical device quality systems. We are not a general consulting practice that offers compliance as one of many service lines, audit and regulatory assurance is our core practice.
Global Regulatory Coverage
We audit organisations that operate across multiple regulatory jurisdictions. Our expertise spans EU regulatory frameworks (EMA, national competent authorities), UK regulatory requirements (MHRA), US FDA requirements, Indian regulatory requirements (CDSCO, Schedule M) and international frameworks including WHO GMP, PIC/S and ICH Q-series guidelines.
Organisations that manufacture or distribute across multiple markets face the challenge of maintaining compliance with multiple simultaneously applicable regulatory frameworks. We bring the cross-jurisdictional expertise to assess compliance effectively and identify where requirements across different frameworks create additional compliance demands.
Sthira Assure is a trading name of Sthira Systems Ltd, a specialist professional services group committed to advancing quality, compliance and operational excellence across the life sciences sector.
Work with Sthira Assure
Contact our team to discuss your audit, assurance or regulatory consulting requirements.