GDP Remediation & Regulatory Recovery

Responsive, expert support for GDP failures, inspections, and Compliance Monitoring (CM).

Even the most well-managed pharmaceutical operations can encounter challenges—whether it’s a failed MHRA inspection, a critical or major deficiency, or an unexpected deviation that threatens your licence.

At GDP Pharma Consulting, we specialise in providing swift, discreet, and regulator-informed GDP remediation support. Led by former MHRA Inspectors and Operations Managers with over 1500 regulatory GDP inspections completed, we have significant experience in citing critical and major deficiencies and how to apply appropriate corrective and preventive actions

Remediation roadmap

We work closely with Responsible Persons (RPs), licence holders, senior leadership, and quality teams to rapidly assess issues and put the right solutions in place, including:

  • Root Cause Analysis (RCA) & Deviation Mapping

We perform in-depth investigations to determine how and why a compliance issue occurred—and how to prevent it recurring.

  • Corrective and Preventive Action (CAPA) Planning

We help you draft realistic, regulator-aligned CAPA plans that address the root cause and stand up to MHRA review.

  • QMS Rebuilding & Documentation

We can revise or rebuild your Quality Management System (QMS), update SOPs, and ensure your system supports compliance and oversight.
Explore our QMS services for more detail.

  • Coaching & Staff Support

We deliver targeted training and 1:1 coaching to ensure staff understand deviations, their impact, and the new controls in place. See our Training services for more detail.

  • Regulatory Communication Support

We can support you in communicating with the MHRA—whether responding to deficiencies, submitting CAPAs, or undergoing re-inspection.

MHRA Compliance Monitor Programme

We are eligible to act as Compliance Monitors (CM) under the MHRA’s pilot GDP Compliance Monitor programme. This scheme allows us to supervise your remediation efforts directly and report on progress to the MHRA—accelerating resolution while rebuilding confidence.

Who We Help

  • Companies with recent MHRA GDP inspection failures

  • Wholesalers referred to MHRA Compliance Monitoring Teams (CMT)

  • WDA holders issued regulatory warnings

  • Organisations recovering from serious deviations or product recalls

  • New RPs needing support in high-pressure remediation settings

  • Businesses looking to rebuild trust with the regulator

Ready to Resolve and Rebuild?

Get in touch for our team help you recover quickly, restore confidence, and rebuild a sustainable, inspection-ready compliance framework.

Phone: 07309 095922 or 07309 094743


Email: admin@gdppharmaconsulting.co.uk