Our services
Compliance expertise, end to end
From validation planning to regulatory submission readiness, Phoenix Biotech delivers the full spectrum of GxP compliance services for regulated industries.
Computer System Validation
Validated systems. Audit-ready documentation.
We manage the complete CSV lifecycle in alignment with GAMP 5, 21 CFR Part 11, EU Annex 11, and ICH Q10 — from initial risk assessment through to final validation summary reports.
Validation Master Plans
Comprehensive VMPs that define the validation strategy, scope, responsibilities, and acceptance criteria across your system portfolio.
IQ / OQ / PQ Execution
Rigorous installation, operational, and performance qualification protocols — written, executed, and reviewed to meet regulatory expectations.
Risk-Based Validation
GAMP 5-aligned risk assessments that focus validation effort where it matters most, reducing cost without compromising compliance.
Legacy System Remediation
Retrospective validation and gap remediation for systems that were implemented before formal validation requirements were in place.
Cloud & SaaS Validation
Supplier qualification, shared responsibility matrices, and validation packages for cloud-hosted and SaaS platforms including LIMS, ERP, and MES.
Periodic Review
Structured Periodic Review programmes to maintain validated status and demonstrate ongoing fitness for purpose.
Data Integrity
ALCOA+. Every record. Every time.
Data Integrity failures remain one of the leading causes of regulatory action. We help organisations build robust, sustainable data governance frameworks that satisfy FDA, MHRA, and WHO expectations.
Data Integrity Gap Assessments
Systematic assessments against ALCOA+ principles, MHRA guidance, and FDA Data Integrity guidance — identifying vulnerabilities before inspectors do.
Remediation Planning & Execution
Prioritised remediation roadmaps with practical, implementable solutions — from audit trail configuration to procedural controls.
Data Governance Frameworks
Policies, procedures, and organisational structures that embed Data Integrity into your quality culture, not just your SOPs.
Staff Training & Awareness
Role-specific training programmes that build genuine understanding of Data Integrity obligations across laboratory, manufacturing, and QA teams.
Regulatory Compliance
Inspection-ready. Always.
Our Regulatory Compliance services span the full GxP landscape — helping you build, maintain, and demonstrate a state of compliance across your quality systems.
Compliance Gap Assessments
Structured assessments against FDA, EMA, MHRA, and ICH requirements — delivering a clear picture of your current compliance posture and a prioritised action plan.
SOP Development & Review
Clear, compliant, and practical standard operating procedures written by practitioners who understand both regulatory requirements and operational realities.
Audit Readiness Preparation
Pre-inspection mock audits, documentation reviews, and staff preparation to ensure your organisation presents confidently to regulatory inspectors.
CAPA Management
Root cause analysis, corrective and preventive action development, and effectiveness checks that satisfy regulatory expectations and prevent recurrence.
Change Control Support
Robust change control processes that manage the compliance impact of system, process, and organisational changes throughout their lifecycle.
Not sure where to start?
Every engagement begins with a no-obligation discovery call. We'll listen, assess, and recommend the right approach for your organisation.
No obligation. Typically respond within 24 hours.