Industries We Serve
Sector-specific expertise,
not generic compliance
Each regulated industry carries its own risk profile, regulatory framework and quality system expectations. Our programmes are built around those specifics — not adapted from one-size-fits-all compliance templates.
Choose your sector
Select your industry to explore the specific services, frameworks and expertise we bring to your regulatory environment.
Pharmaceuticals
End-to-end GMP compliance, from site audits to inspection readiness
Deep expertise across solid dose, sterile, API and semi-solid manufacturing. We audit against EU GMP, FDA 21 CFR 210/211, WHO GMP and PIC/S — and deliver findings that hold up under regulatory scrutiny.
Biotechnology
Quality systems built for the complexity of biological medicines
From cell and gene therapy to biosimilars and biological APIs, we audit quality systems against the specific expectations of biologic manufacturing — including EU GMP Annex 2, ICH Q5 series and ATMP regulations.
Medical Devices
Navigating MDR, IVDR and ISO 13485 with confidence
We support device manufacturers through regulatory transitions, Notified Body assessments and ongoing ISO 13485 quality system compliance — covering everything from design controls to post-market surveillance.
CDMOs
Rigorous independent qualification for contract manufacturers
Contract manufacturers face multi-client scrutiny from sponsors with different standards and expectations. We provide independent qualification and periodic audits that satisfy the requirements of multiple pharmaceutical clients simultaneously.
CROs
GCP oversight from protocol to final study report
We conduct sponsor oversight audits, investigator site qualifications and TMF completeness reviews for contract research organisations — covering ICH E6(R2), EU CTR and FDA 21 CFR Part 312 requirements.
Wholesale Distributors
GDP compliance and cold chain assurance across the supply chain
We audit licensed wholesale dealers, 3PL providers and parallel importers against EU GDP, MHRA GDP and WHO guidelines — including cold chain qualification, temperature excursion management and FMD serialisation compliance.
Our Approach
How we work across every sector
Whatever the industry, our engagements follow the same principled methodology — adapted to the regulatory context, not templated regardless of it.
Framework-matched
We audit against the exact regulations that govern your sector and geography — not a generic checklist applied across industries.
Risk-calibrated
Scope and depth are proportionate to the actual regulatory risk profile of your organisation, products and processes.
Inspector-aware
Findings reflect current inspector expectations and enforcement trends, not textbook interpretations of guidelines.
Actionable
Every recommendation is grounded in industry practice — practical to implement, not just technically correct on paper.
Get Started
Not sure where to begin?
Tell us about your regulatory environment and we will design an audit and assurance programme appropriate to your specific sector, geography and risk context.