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Consultancy GDP Transport Compliance Netherlands-based, worldwide support

Voluntary GDP Certification for Transportation Companies

PCS engages when transport and logistics companies need GDP certification to translate into how drivers, dispatchers and warehouse staff actually behave with pharmaceutical loads. Compliance becomes part of the operational DNA — so client audits and certification bodies see a working system, not a binder.

260+ organisations
500+ audits
10,000+ trained

When this is the right fit

PCS engages with transport and logistics leadership when:

A pharmaceutical manufacturer or wholesaler client has set a deadline of 6–12 months for GDP certification as a condition of contract renewal

A tender for pharmaceutical logistics has been lost in the past 12 months because of missing GDP certification or weak quality evidence

A temperature excursion or product complaint has reached a pharmaceutical client and exposed gaps in your current quality framework

Your fleet has expanded into temperature-controlled or biological products without a formal qualification or driver competency programme

A pharmaceutical client has completed an on-site audit of your operation and produced findings on routing, temperature monitoring or training records

When this is not the right fit

When you should look elsewhere

  • You want a certificate on the wall without changing how drivers and dispatchers handle pharmaceutical loads
  • You expect a copy-paste pharmaceutical warehouse QMS rather than a quality system designed for road and warehouse operations
  • You are looking for the lowest day-rate option — GDP certification work is led by senior partners who have audited transport providers themselves
  • You do not have management buy-in to invest in driver training, vehicle qualification or temperature monitoring

What you get

We build a GDP-compliant operation that is practical for transport companies, not a copy-paste from a pharmaceutical warehouse.

GDP Quality System for Transport

A complete quality management system designed for transport and logistics operations. Covers route management, temperature control, vehicle qualification, cleaning procedures, and personnel training -- all aligned to EU GDP guidelines for transportation.

Documentation Package

All required SOPs, work instructions, forms, and records templates built for your specific fleet and operations. Documentation is written in practical language your drivers and dispatchers can work with daily.

Temperature Mapping & Monitoring

Guidance on temperature mapping of vehicles, qualification protocols, and continuous monitoring solutions. We help you select appropriate equipment and establish procedures that satisfy client audits.

Certification Audit Preparation

Preparation for the certification audit including internal audits, management review, and mock audit sessions. Your team knows exactly what to expect and how to present your operation to the certification body.

How we work

The path to certification depends on your starting point. We offer three engagement models.

Assessment Only

2-3 weeks

For companies that want to understand the gap before committing to full certification

Typical deliverables

  • GDP gap assessment for transport operations
  • Roadmap to certification with effort and cost estimates
  • Management briefing on requirements and timeline
Full Certification Programme

3-6 months

End-to-end support from quality system build to successful certification

Typical deliverables

  • Complete GDP quality system development
  • Personnel training and competency programme
  • Internal audit, mock audit, and certification audit support
Maintenance & Growth

Ongoing

Post-certification support to maintain compliance and expand scope

Typical deliverables

  • Annual internal audit and management review support
  • Surveillance audit preparation
  • Scope extension guidance for new routes or services

Typical timeline

1

Gap Analysis & System Design

We assess your current operations, fleet, and processes against GDP requirements for transportation. Within two weeks, you have a clear picture of what needs to be built and a phased implementation plan.

2

Implementation & Training

The quality system is implemented step by step: documentation, temperature monitoring, vehicle qualification, personnel training, and operational procedures. Each element is tested in your real operations before moving to the next.

3

Audit & Certification

An internal audit verifies full system readiness. After any remaining corrections, the certification body conducts their audit. With thorough preparation, companies typically achieve certification on the first attempt.

What clients see

Example (anonymised)

A regional transport company with 40 vehicles and no pharmaceutical experience needed GDP certification to retain a major wholesaler contract. PCS built the complete quality system, trained all drivers and warehouse staff, and managed the certification process so the dispatch and driver behaviour matched what the certifying body would see. The company achieved certification within five months and has since expanded its pharmaceutical client base.

See more clients and outcomes →
"We are a transport company, not a pharmaceutical company. PCS translated GDP into language and processes our team could actually use. The certification opened a new revenue stream for us."

Operations Director at a European regional transport and logistics company

Frequently asked questions

GDP certification for transport is voluntary -- there is no legal obligation. However, pharmaceutical manufacturers and wholesalers increasingly require it from their transport partners. In practice, it is becoming a market access requirement for pharmaceutical logistics contracts.

We align to the EU GDP guidelines (2013/C 343/01) and work with recognised certification bodies. The specific certification scheme depends on your market and client requirements. We advise on the most appropriate option for your situation.

Yes. GDP requires that all personnel involved in the distribution of medicinal products receive appropriate training. We develop a practical training programme that covers GDP awareness, temperature management, hygiene, and incident reporting -- tailored to the daily reality of drivers.

Vehicle temperature mapping and qualification are core elements of GDP certification. We help you establish qualification protocols for your fleet, select monitoring equipment, and set up procedures for temperature excursions. This applies to both active (refrigerated) and passive (insulated) solutions.

Costs depend on fleet size, scope of operations, and your starting position. We provide a detailed estimate after the initial gap assessment. The investment typically pays for itself through access to pharmaceutical contracts and improved operational reliability.