Regulatory Compliance

We help life-sciences and regulated organisations meet GxP, CSV and data-integrity requirements with practical, audit-ready programmes — so compliance supports your business instead of slowing it down.

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Making compliance feel manageable

We translate complex regulatory expectations into clear, actionable programmes your teams can actually follow.

From CSV and Part 11 through to data integrity and GxP operating models, we help you build controls that stand up to inspection — without drowning people in paperwork. Our consultants work alongside your SMEs, QA and IT teams to close gaps, strengthen evidence trails, and embed sustainable compliance habits.

We support:

21 CFR Part 11
EU Annex 11
GxP Frameworks
GAMP 5 guidance

Computer Systems Validation (CSV)

Risk-based validation of GxP systems — from URS and risk assessment through IQ, OQ and PQ — with documentation your auditors will trust.

GxP Compliance Programmes

End-to-end programme design covering policies, SOPs, training and quality oversight aligned to your operating model.

21 CFR Part 11 Assessments

Gap analysis and remediation for electronic records and signatures, including access controls, audit trails and validation evidence.

Cloud & SaaS Validation

Practical validation approaches for cloud platforms and SaaS tools, balancing vendor documentation with your quality requirements.

Data Integrity Support

ALCOA+ assessments, remediation roadmaps and control design to protect the reliability of your critical quality and clinical data.

Training & Capability Building

Role-based workshops and coaching that help QA, IT and business teams understand their compliance responsibilities.

Experience that makes a difference

Our consultants have delivered CSV, Part 11 and data-integrity programmes across pharma, biotech and med-tech — so you get insight grounded in real inspections, not theory.

Practical, not over-engineered

We right-size controls to your risk profile. No bloated documentation packs — just what you need to demonstrate compliance and keep operations moving.

We work with your team, not around them

We embed alongside QA, IT and business owners so knowledge stays in-house and improvements stick after we leave.

Who We Work With

Pharma & biotech
Medical devices
Health tech & digital health
CDMOs & contract research
Diagnostics & laboratories

Clear, plain-English deliverables

Reports, validation packs and remediation plans written for humans — so stakeholders understand what was done, why, and what happens next.

Ready to make compliance simpler?

Talk to our regulatory team about your next inspection, system go-live or gap assessment — we'll help you plan a proportionate path forward.

Book a discovery call Request a gap assessment