Precision Audit Intelligence for the Life Sciences Value Chain
Sthira Assure delivers expert-led, risk-based audit and qualification services across GMP, GCP, GLP, GVP, GDP, Medical Devices, and Digital Systems — giving life sciences organisations the independent assurance they need to operate, grow, and comply with confidence.
End-to-End Compliance Coverage
Six GxP disciplines spanning the full pharmaceutical and medical device lifecycle — from early development through commercialisation and post-market surveillance.
GMP Oversight & Material Qualification
Comprehensive audits spanning API manufacturers, excipient suppliers, CDMOs, ATMPs, sterile processing, and PAI readiness — aligned with ICH Q7 and ICH Q9.
- API & Intermediate Manufacturer Audits
- CDMO / Contract Manufacturer Qualification
- ATMP Specialised Audits
- Sterile & Aseptic Processing Appraisals
- Pre-Approval Inspection (PAI) Readiness
Clinical Trial & Clinical Quality Valuations
Site audits, CRO qualification, TMF completeness reviews, and decentralised trial technology appraisals to keep your clinical programmes compliant and on schedule.
- Clinical Trial Site Audits
- Sponsor & CRO Process Audits
- Trial Master File (TMF) Completeness Audits
- Investigator Qualification Appraisals
- Decentralised Clinical Trial (DCT) Tech Appraisals
GLP & Analytical Laboratory Appraisals
GLP facility audits, ISO 17025 competence assessments, bioanalytical lab appraisals, and forensic raw data spot-checks for analytical integrity assurance.
- GLP Facility Audits (21 CFR Part 58 / OECD)
- ISO 17025 Laboratory Competence Audits
- Bioanalysis & Pharmacokinetic (PK) Lab Appraisals
- Outsourced Bioanalytical Vendor Audits
- Analytical Method & Raw Data Spot-Checks
GVP & Post-Market Safety Systems
SDEA/PVA compliance audits, QPPV network appraisals, PSMF integrity reviews, and signal detection process checks across your full pharmacovigilance ecosystem.
- SDEA & PVA Contractual Compliance Audits
- Outsourced Safety Vendor & CRO Qualification
- QPPV & Local Affiliate Network Appraisals
- PSMF Integrity Audits
- Signal Detection & Literature Review Appraisals
GDP & Supply Chain Logistics
Wholesale distributor audits, cold chain mapping, controlled substance logistics, and 3PL vendor qualification to protect your supply chain integrity globally.
- Wholesale Distributor & Broker Audits
- Cold Chain & Temperature Storage Mapping
- Controlled Substance Logistics Appraisals
- 3PL Vendor Qualification Audits
Medical Device Diagnostics & Global Frameworks
ISO 13485, MDSAP multi-country compliance, EU MDR/IVDR transition audits, and PRRC framework verification across your device quality management system.
- ISO 13485 QMS Assessments
- MDSAP Audits (US, CA, BR, JP, AU)
- EU MDR / IVDR Transition Audits
- PRRC Framework Auditing
Specialist Assurance Beyond GxP
From digital systems and data integrity to M&A risk screening and supply chain serialization — our specialist teams extend compliance coverage across your entire enterprise.
Enterprise Quality Management
ISO 9001, ISO 27001, ISO 14001, and ISO 45001 framework audits covering quality, information security, environmental, and occupational health compliance.
Nutraceutical & Food Safety Systems
HACCP hazard analysis and GFSI-benchmarked scheme evaluations for nutraceutical manufacturers and food supply chain participants seeking certification.
Computer System Validation (CSV)
IT vendor qualification, SDLC assessments, and CSV documentation gap audits aligned with FDA 21 CFR Part 11 and EudraLex Annex 11 requirements.
Data Integrity & ALCOA+ Lifecycles
End-to-end data lifecycle appraisals and hybrid paper-to-electronic forensic reviews ensuring data remains Attributable, Legible, Contemporaneous, Original, and Accurate.
M&A Due Diligence & Technical Risk
Rapid regulatory liability screening of target company facilities, product portfolios, and historical compliance records to inform acquisition decisions.
Serialization & Track & Trace
DSCSA and EU FMD compliance verification — barcoding, aggregation audits, and interoperable data exchange checks across the pharmaceutical supply chain.
Flexible, Scalable Audit Delivery
Whether on-site or remote, project-based or fully managed, Sthira Assure adapts to your operational rhythm and compliance calendar.
On-Site Audits
Physical facility presence for audits requiring direct process observation, equipment inspection, and personnel interviews — the gold standard for high-risk manufacturing and laboratory sites.
- GMP manufacturing site audits
- Laboratory facility & GLP audits
- Warehouse & logistics inspections
- PAI readiness & regulatory mock audits
Remote & Hybrid Appraisals
High-definition video facility walkthroughs, secure cloud document parsing, and smart-glass integrations — faster, cost-effective, and carbon-neutral without sacrificing rigour.
- Reduced travel cost & carbon footprint
- Document-heavy audits (TMF, PSMF, CSV)
- Rapid supplier qualification checks
- Ideal for SME clients across time zones
Centralised Programme Management
We manage your entire annual audit pipeline — scheduling, resource coordination, report consolidation, and CAPA tracking — across dozens of global facilities and supplier relationships.
- Annual audit calendar management
- Multi-site global coordination
- Supplier audit programme oversight
- CAPA trend reporting & dashboards
Why Organisations Trust Sthira Assure
Life sciences organisations choose Sthira Assure because they need more than a checkbox audit. They need an independent partner who understands the regulatory landscape as deeply as they do — and who will tell them the truth.
Risk-Based Methodology
Every audit is scoped using ICH Q9-aligned risk principles, directing effort where it matters most — not distributed uniformly across low-impact processes.
Regulatory-Grade Expertise
Deep, sector-specific knowledge across international regulatory frameworks. No generalists — every assignment draws on practitioners with direct GxP experience in the relevant domain.
Independent Objectivity
As a specialist independent firm, we operate with no commercial conflicts. Our findings reflect what we observe — providing genuine assurance value rather than compliance theatre.
Actionable Intelligence
Audit reports structured for action — clear risk-rated findings, root-cause analysis, and implementable CAPA guidance. Compliance documentation that drives real improvement.
Ready to Strengthen Your Compliance Posture?
Our team is ready to scope your next audit — whether it's a single supplier qualification or a fully managed global compliance programme.