Trusted Experts in MHRA GDP Compliance, Audits & Remediation

At GDP Pharma Consulting, we offer unrivalled expertise in Good Distribution Practice (GDP) compliance, inspection readiness, and remediation. Our co-founders, Peter and Claire, are uniquely qualified to act as Compliance Monitors (CM) under the MHRA’s pilot Compliance Monitor programme, offering supervised support during GDP remediation activities for wholesale distributors.

As a Team we bring over 50+ years of combined experience in the pharmaceutical industry, including more than 25 years within the MHRA's GDP Inspectorate. Both Peter and Claire have served as Senior Inspectors, Operations Managers, and regulatory advisors to some of the most complex and high-risk operations across the UK wholesale distribution network.

Having personally conducted over 2,000 GDP inspections, they offer unparalleled insight into MHRA expectations, GDP enforcement trends, and compliance best practices. Their knowledge spans specialist and large-scale operations, as well as challenging sites under regulatory scrutiny.

Our Core Services Include:

• Bespoke GDP training courses tailored to your team and operations

• General GDP consultancy and ongoing compliance support

• Contract RP (Responsible Person) & RPi (Responsible Person for Import) services

• Full GDP Quality Management System (QMS) design and implementation

• Expert SOP development and GDP document review

• Internal GDP audits and pre-inspection readiness assessments

• External third-party contractor GDP audits

• WDA(H) application support and guidance on MHRA Wholesale Dealer’s Authorisation

• Remediation support for MHRA inspection failures, non-compliance notices, or CAPA management

Expert GDP Training Experience

We have designed and delivered high-impact GDP training sessions for both industry professionals and MHRA Inspectors, with specialist topics including:

• QMS and GDP documentation

• Quality Risk Management (QRM)

• Root Cause Analysis and CAPA

• GDP-compliant Transport Risk Assessment

• Validation principles for distribution operations

Training is available on-site, remotely, or through open courses, and is always adapted to meet the needs of your team and your licence.

Why GDP Pharma Consulting?

• Owned and operated by two former MHRA GDP Senior Inspectors

• Over 2,000 inspections conducted across every type of GDP operation

• Recognised Compliance Monitors (CM) under MHRA’s GDP pilot scheme

• Extensive and up to date knowledge of inspection trends, regulator expectations, and how to get back on track after a failed audit

• Members of the UK Warehousing Association (UKWA)

• Proven record in GDP remediation, RP support, and licensing success

Whether you are preparing for inspection, navigating a GDP compliance crisis, applying for a WDA licence, or simply want to strengthen your internal quality systems, GDP Pharma Consulting offers practical, expert-driven solutions tailored to your business.

Compliance Monitoring

Peter and Claire are able to act as Compliance Monitors (CM) in the MHRA’s pilot compliance monitor programme for GDP remediation supervision activities