GDP Consultancy
PCS engages when GDP compliance has to become operational behaviour, not a paper exercise. We embed quality into how your wholesale, cold chain and transport operations actually run — so inspections and client audits stop being events to survive.
When this is the right fit
PCS engages with GDP-responsible leaders when:
A competent authority has scheduled a GDP inspection within the next 90 days and your last self-inspection surfaced unresolved issues
More than three temperature excursions in the past quarter have closed without a root cause that changed operational behaviour
A new WDA application is in progress and the supporting quality system was written for a smaller, simpler distribution scope
The same deviation type (mis-shipments, lane breaches, supplier qualification gaps) has reappeared across two or more management reviews
You just received a critical or major finding from a client audit or competent authority that calls your quality culture into question
When this is not the right fit
When you should look elsewhere
- You need a tactical SOP rewrite without addressing why the previous SOP was not followed
- You are looking for a GDP certificate without changing how your dispatch and cold chain teams behave day to day
- You want the lowest day-rate option — our GDP work is led by senior partners, not staff augmentation
- You expect a consultant to take ownership of compliance instead of building it into your own line management
What you get
Our GDP consultants deliver practical, implementable outcomes — not shelf reports.
GDP Gap Analysis
A structured assessment of your distribution operations against current EU GDP guidelines. You receive a prioritised action plan with clear ownership and timelines.
Quality System Design & Remediation
Development or overhaul of your GDP quality system: SOPs, change control, CAPA processes, deviation handling, and document management — built to withstand inspection.
Cold Chain & Transport Compliance
Temperature mapping, transport validation, lane qualification, and packaging verification. We ensure your cold chain documentation meets regulatory expectations end-to-end.
GDP Inspection Preparation
Mock inspections, back-room coaching, and inspection-day support. We prepare your team for the questions inspectors actually ask — and the evidence they expect to see.
Supplier & Carrier Qualification
Qualification frameworks for transport providers, warehouse operators, and third-party logistics partners. Risk-based, proportionate, and audit-ready.
How we work
We structure every GDP engagement around your specific situation. Three common starting points:
1–2 weeks
Know where you stand
Typical deliverables
- On-site GDP gap assessment against EU guidelines
- Prioritised findings report with risk classification
- Recommended action plan with indicative timelines
4–12 weeks
Fix what matters most
Typical deliverables
- Focused improvement of critical GDP gaps
- SOP development or revision for distribution processes
- Cold chain documentation and validation support
Flexible
Sustained compliance
Typical deliverables
- Dedicated GDP consultant available on a retained basis
- Periodic compliance reviews and internal audit support
- Regulatory intelligence on GDP guideline updates
Typical timeline
Scoping & Assessment
We review your current GDP documentation, visit your site, and assess operations against applicable guidelines. Within the first week you receive a clear picture of compliance status and risk areas.
Planning & Execution
Together we agree priorities and a realistic timeline. Our consultants work alongside your team — writing SOPs, redesigning processes, qualifying suppliers, or preparing inspection responses. No handoff to junior staff.
Verification & Handover
Before we step back, we verify that changes are embedded: documentation is complete, staff are trained, and your quality system can sustain compliance independently. You keep all deliverables and templates.
What clients see
Example (anonymised)
A European pharmaceutical wholesaler expanding into temperature-sensitive biologics engaged PCS to overhaul their GDP quality system. Within 10 weeks we redesigned their cold chain documentation, qualified three new transport lanes, and walked dispatch, QA and transport supervisors through the inspection narrative they would have to defend. The subsequent regulatory inspection resulted in zero critical findings.
See more clients and outcomes →"PCS understood our distribution operations from day one. They did not just write documents — they changed how we run cold chain. Our inspection result speaks for itself."
Frequently asked questions
Good Distribution Practice (GDP) is the regulatory standard governing the wholesale distribution of medicinal products. It ensures that product quality is maintained throughout the supply chain — from manufacturer to pharmacy or hospital. Compliance is a legal requirement for holding a Wholesale Distribution Authorisation (WDA) in the EU.
In most cases we can begin within one to two weeks. For urgent situations — such as an announced inspection or a critical audit finding — we prioritise rapid deployment and have started engagements within days.
Both. Gap assessments, mock inspections, and process observation require on-site presence. Documentation review, SOP writing, and training development can be done remotely. We agree the most effective mix at the start of each engagement.
Yes. While our primary expertise is EU GDP (Guidelines of 5 November 2013), we have supported organisations with WHO GDP, PIC/S requirements, and country-specific regulations across multiple continents.
A gap analysis identifies where your operations fall short of GDP requirements and produces a remediation plan. An audit is a formal, structured evaluation — often of a supplier or third party — that results in an audit report with classified observations. We perform both, and often a gap analysis is the first step before broader remediation work.