GxP Audits & Supply Chain
Comprehensive GMP, GDP, GLP, and supply chain audits ensuring regulatory compliance
- Sterile & non-sterile medicinal products
- API and API intermediates
- Contract laboratories & GDP distributors
Comprehensive GxP Services
From GxP audits and regulatory compliance through to validated software development — every service is tailored to your product type, your facility and your regulatory landscape.
12 Practice Areas
EU, UK, Asia & Africa
ISO 9001:2015 Focused
Our Services & Solutions
Every Discipline Your Quality System Depends On
Select a service to see the full methodology, deliverables and regulatory frameworks we work to.
GxP Documentation
SOPs, validation protocols, quality manuals, and compliant documentation systems
- Writing documents from scratch
- Reviewing & improving existing SOPs
- WHO, FDA, EMA and ANVISA alignment
Validation & Qualification
Process, cleaning, utilities, equipment, and computerized system validation
- IQ, OQ and PQ protocol development
- Process and cleaning validation
- CSV to 21 CFR Part 11 / Annex 11
EU Inspection Readiness
Gap assessments, mock audits, remediation planning, and expert preparation
- EU GMP reviews and gap analysis
- Pre-inspection audit by EU partner
- Application submission and liaison
PIC/S Compliance
Gap assessments, mock audits, remediation planning, and expert preparation
- PIC/S reviews and gap analysis
- Pre-inspection audit by PIC/S partner
- Authority submission and liaison
GMP Training
Practical GMP and GxP training programs for pharmaceutical and biotech teams
- Foundational GMP for all personnel
- Data integrity and ALCOA+ principles
- Internal auditor certification tracks
eQMS / eDMS / LIMS
Digital quality management, document control, and laboratory management software
- eQMS with full audit trail and e-signatures
- eDMS controlled document lifecycle
- WMS and LIMS for GDP and GLP
Clinical Study Support
Regulatory and operational support for clinical studies and compliance
- Safety, efficacy and dosage evaluation
- Phase I–IV study support
- Pharmacokinetic assessment
MA Holding Services
Marketing authorization holding services with regulatory coordination
- Regulatory affairs and CTD/eCTD dossiers
- Pharmacovigilance and EU-QPPV
- Qualified Person batch release
Warehousing Services
GDP-compliant warehousing and distribution across multiple regions
- Temperature-controlled product storage
- Receipt, checking and order preparation
- Bulk storage and batch traceability
Turnkey Projects
End-to-end pharmaceutical facility setup, compliance planning, qualification
- Feasibility studies and master planning
- Facility design and engineering
- Construction, commissioning and validation
Technology Transfer
Structured technology transfer support ensuring process consistency
- R&D to production transfer
- Site-to-site and scale-up transfer
- Validation batches and dossier amendments
Assessment
Ready to Elevate Your GxP Compliance Strategy?
Start with a free gap assessment. We review your current state against your target market’s expectations and tell you exactly what stands between you and approval.
How We Engage
One Partner Across the Whole Lifecycle
Most clients start with a single audit or gap assessment. What keeps them is that the same team can carry the work through documentation, validation, training, software and inspection — without re-explaining the facility to a new supplier at every stage.
- Project-based — a defined audit, protocol set or remediation package.
- Retained — ongoing QA capacity with agreed response times.
- Embedded — our consultants working on site inside your quality organisation.
01
Scope & Gap Read
We establish target market, product category and current compliance posture.
02
Proposal & Roadmap
A costed plan with sequencing, resourcing and realistic timelines.
03
Delivery
Execution on site and remotely, with progress visible against the roadmap.
04
Closure & Follow-Up
Sign-off, handover and periodic re-verification to keep compliance live.
Let’s Talk
Ready to Transform Your GxP Strategy?
Book a no-obligation call with a senior consultant and get practical answers about your specific facility, product and market.