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Quality Assurance

Quality Management System Implementation

We develop GxP Quality Management Systems and GxP procedures for pharmaceutical manufacturers & wholesalers

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What is a Quality Management System (QMS) in pharma?

A Quality Management System (commonly abbreviated as QMS) is a collection of documents that aims to attain a quality objective. A Quality Management System is referred to as a Pharmaceutical Quality System (PQS) in the WHO and EU GMP regulatory guidelines.

Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice.

What QMS services does PCS offer?

QMS set-up from scratch,
QMS repair following government inspection,
QMS revision to latest GxP standards,
Single SOP review and upgrade,
Writing qualification or validation protocols,
Upgrading your current QMS from (e.g.) ISO to GMP or GDP,

Efficient and compliant QMS implementation

PCS has developed a large database of GMP and GDP procedures over the past 34 years. Our experience combined with this large database allows PCS to implement or upgrade your quality system quickly.

Our procedures are continually tested during regulatory inspections at our clients and updated accordingly. We can deliver a GDP quality system template set starting from € 1,000.-. All you need to do is add your details to get a fully compliant set of GDP SOP’s.

Why choose PCS' consultancy services?

Extensive experience in regulatory inspections and audits,
Our consultants are ex-regulatory inspectors and industry experts, having conducted more than 300 audits each,
Thanks to our international clients we can prepare clients for every regulatory inspection; EU GMP, U.S. FDA, WHO GMP or a combination of these regulatory frameworks,
We know what your clients or the government expects and inspects!
Julian Koster, Business Development

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Regulatory frameworks

PCS can implement a Quality Management System in GMP or GDP for any major international regulatory framework. We are specialized in the following GxP regulatory frameworks:

  • European Union GMP,
  • U.S. FDA GMP,
  • World Health Organization GMP,
  • PIC/S GMP,
  • ICH GMP.


We can implement Quality Management Systems for the following industry types:

  • Pharmaceutical,
    • Finished Product including Medicinal Cannabis,
    • Intermediates,
    • API including Medicinal Cannabis,
    • Excipients.
  • Biotechnology,
  • Chemical,
  • Food,
  • Medical
    • Hospitals,
    • Pharmacies.

Have a question about our gap assessment services?

We’re here to help! We usually respond within 1 hour or business day.

Extensive EU GMP, WHO GMP & U.S. FDA GMP experience,
We help clients worldwide,
We respond to gap inspection requests within the hour
We provide actionable improvements in our gap assessment reports,

Contact us

We have the expertise and experience to perform highly beneficial gap assessments worldwide!

Jaap Koster
Jaap Koster

Senior GMP & GDP Consultant

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Available M-F: 09:00 AM to 5:00 PM

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