Trusted compliance partners
Navigate complexity. Deliver compliance.
Phoenix Biotech guides biotech, pharma, and medical device organisations through Computer System Validation, Data Integrity, and Regulatory Compliance — with precision and confidence.
What we do
End-to-end compliance expertise
We bring deep GxP knowledge and hands-on experience to every engagement, helping regulated organisations achieve and maintain compliance without disruption.
Computer System Validation
Comprehensive CSV services aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11. From validation planning through IQ/OQ/PQ execution to final reporting — we manage the full lifecycle.
Data Integrity
Robust Data Integrity programmes built on ALCOA+ principles. We assess, remediate, and strengthen your data governance frameworks to meet FDA and MHRA expectations.
Regulatory Compliance
Strategic compliance support across GxP disciplines — from gap assessments and SOP development to audit readiness and inspection preparation for global regulatory submissions.
Why Phoenix Biotech
A partner built for regulated industries
Precision. Compliance. Partnership.
Deep GxP expertise
Our consultants bring decades of hands-on experience across FDA, EMA, MHRA, and ICH frameworks — giving you confidence in every deliverable.
End-to-end support
From initial gap analysis through validation execution to ongoing compliance maintenance, we support the full lifecycle of your regulated systems.
Proven track record
Successful engagements across clinical, manufacturing, and laboratory environments — delivering audit-ready documentation and zero critical findings.
True partnership approach
We work alongside your teams, transferring knowledge and building internal capability — not creating dependency.
Industries we serve
Expertise across regulated sectors
Biotechnology
Cell and gene therapy, biologics, and emerging biotech platforms
Pharmaceuticals
Commercial manufacturing, clinical trials, and quality systems
Medical Devices
Software as a Medical Device (SaMD), IVD, and combination products
Ready to simplify your compliance journey?
Whether you're preparing for an inspection, implementing a new system, or building your compliance programme from the ground up — we're here to help.
No obligation. Typically respond within 24 hours.