GxP Compliance & Risk Consulting
Know exactly where you stand before a regulator, partner or investor looks. We identify compliance gaps, assess risk and put practical, proportionate controls in place — so your operations stay compliant as you grow.
Compliance problems rarely appear overnight. They build up quietly: procedures drift from practice, risks go unassessed, training falls behind and data integrity controls weaken. By the time an inspector, auditor or partner finds them, fixing them is urgent and expensive.
Radical Pharma Consultancy helps you find and fix these issues early. Our consultants have worked inside regulated pharmaceutical operations and apply a risk-based approach consistent with ICH Q9(R1), focusing your effort where it matters most for patient safety, product quality and regulatory standing.
The result is a clear picture of your compliance position, a prioritised plan to close gaps and a team that understands why the controls matter.
Compliance & Risk Services
Gap Assessments
An objective review of your systems and practices against the regulations and guidance that apply to you.
- GMP, GCP and GLP gap assessments
- Pre-inspection and pre-partnering assessments
- Risk-graded findings with a prioritised action plan
- Follow-up verification of remediation
Quality Risk Management
Structured, documented risk management that supports better decisions.
- Risk management plans and procedures (ICH Q9(R1))
- FMEA and other risk assessment tools
- Risk registers and periodic risk review
- Risk-based approaches to validation and supplier oversight
Mock Inspections & Audits
Realistic rehearsals that expose weaknesses before regulators do.
- Mock FDA, Health Canada, MHRA and EU-style inspections
- Internal audit programmes and audit execution
- Interview coaching for subject-matter experts
- Clear reports with practical corrective actions
Compliance Training
Training that builds understanding, not just attendance records.
- GxP fundamentals for new and non-technical staff
- Role-specific training for QA, operations and management
- Data integrity and good documentation practice (ALCOA+)
- Training needs analysis and effectiveness checks
Policy & Procedure Development
Policies and procedures that reflect how your organisation really works.
- Corporate quality and compliance policies
- SOPs aligned with regulatory requirements
- Procedure harmonisation after growth or acquisition
- Commercial compliance programme support
Data Integrity & CAPA Effectiveness
Strong root-cause analysis and trustworthy data are the foundation of every compliant operation.
- Data integrity assessments and remediation
- Root-cause analysis using Lean Six Sigma tools
- CAPA programme review and effectiveness checks
- Deviation and investigation quality improvement
A Risk-Based Approach
Scope
We agree the regulations, sites, systems and risks in scope, and the outcome you need — for example inspection readiness or a partner audit.
Assess
We review documents, observe practice and interview staff to build an accurate picture of your compliance position.
Prioritise
Findings are graded by risk, and you receive a practical remediation plan with owners and timelines.
Remediate
We support you in closing gaps, train your team and verify that corrective actions are effective.
Who We Support
- Companies preparing for a regulatory inspection or customer audit
- Organisations that have received inspection observations or warning letters
- Businesses preparing for investment, licensing or acquisition due diligence
- Growing companies whose procedures have not kept pace with operations
- Teams seeking independent, objective compliance assurance
Independent, Practical Assurance
- ISO 9001 Lead Auditor and Lean Six Sigma Green Belt certified leadership
- Decades of combined experience in regulated pharmaceutical operations
- Familiarity with FDA, Health Canada, MHRA and EU inspection approaches
- Commercial compliance expertise for the US market
- Findings you can act on, not generic checklists
Common Questions About Compliance & Risk
What is the difference between a gap assessment and a mock inspection?
A gap assessment is a systematic review of your systems against specific requirements, producing a full picture of gaps and priorities. A mock inspection simulates how a regulator would inspect you, including interviews and document requests, to test readiness under realistic conditions. Many clients do a gap assessment first and a mock inspection closer to the real event.
How long does a gap assessment take?
It depends on scope. A focused assessment of one system or process can take a few days; a site-wide GMP assessment typically takes one to two weeks including reporting. We agree timelines before we start.
We have received inspection observations. Can you help?
Yes. We help you understand the findings, investigate root causes, draft a credible response and implement corrective and preventive actions that address the underlying issues rather than only the symptoms.
Can training be delivered remotely?
Yes. We deliver live virtual sessions, on-site workshops or a combination, and can tailor content and examples to your products and processes.
How are compliance projects priced?
Most gap assessments and mock inspections are fixed-fee once scope is agreed. Ongoing compliance support can be provided on a day-rate or retainer basis. We start with a free discovery call.
Often Combined With
2026 GxP Inspection Readiness Checklist
A practical self-assessment covering eight areas inspectors focus on — from data integrity and CAPA to inspection logistics — plus a 90-day readiness timeline.
Let's Review Your Compliance Position
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.