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GxP Auditing Services

We perform detailed GxP audits of your third party suppliers. We identify the current qualification status, helping you to identify potential risks in your supply chain.

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Over 550 audits performed, worldwide!

Why you should outsource your audits to PCS!

We audit worldwide,
More than 550 companies audit against the international GxP's,
We usually respond within the hour to urgent requests,
We take care of the entire audit process or program.

Worldwide GxP Auditing

We perform detailed GxP audits of your third party suppliers. We identify the current compliance status of your suppliers, helping you identify potential risks in your supply chain.

Clients ask us to qualify suppliers and contractors in the pharmaceutical industry and biotech industry. Our auditing services are worldwide and cover every major regulatory framework.

Julian Koster, Business Development

Curious to see how we can help you with auditing your suppliers? Plan a call today!

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What type of audit service do you need?


Auditing individual suppliers.

Our auditing services include; coordination with the auditee, audit preparation, audit execution (on-site or remote) and reporting.


Supplier qualification program management.

Save time and resources by outsourcing your audit program management to PCS. We perform the risk ranking, prioritize the audits, prep-work, execution and complete follow-up.

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 and consultants we can prepare clients for every regulatory inspection; EU GMP, U.S. FDA CGMP, WHO GMP or a combination of these regulatory frameworks,
We know what your clients or the government expects and inspects!
Julian Koster, Business Development

Let me help you explore all the benefits of our services!

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Audit experience

PCS has a large team of qualified GxP auditors. With extensive experience in running international audit programs. We have organized and executed corporate audit programs for a number of multinationals like Sandoz, Novartis and Norgine International.

Our experience makes us the ideal partner to outsource your audit program to. PCS’ international scope allows us to be flexible, fast and deliver high quality audit reports. We can perform audits on any continent or country.

We audit any type of pharmaceutical supplier, including (but not limited to); drug products (medicinal products), excipients, active pharmaceutical ingredients (active/drug substances), laboratories, distributors, warehouses, laboratories and software/service providers. Our expertise lies primarily with the EU/WHO/US (C)GxP’s. Other international standards like ICH, PIC/S and ISO 13485 can also be audited against.

Which regulations can PCS audit?

PCS can audit against the United States FDA (C)GMP, World Health Organization GMP, EU GMP, PIC/S and ICH regulatory requirements.

Good Manufacturing Practice (GMP)
Auditing pharmaceutical manufacturers or importers against the GMP’s.
Good Laboratory Practice (GLP)
Auditing pharmaceutical laboratories and contract laboratories against the GLP’s.
Good Distribution Practice (GDP)
Auditing warehouses and distributors of medicinal products against the GDP’s.
Good Clinical Practice (GCP)
Auditing clinical trial providers against the GCP’s.

Mock audits

We perform mock audits of companies to prepare for regulatory inspections or client audits.

The mock audits can be performed against the EU GMP, WHO GMP or U.S. FDA CGMP.

During the mock audit, and the preparation, the auditor(s) will not only make observations but make recommendations for improvement as well.

Auditor training

If you are interested in training your employees in the GMP's or GDP's, have a look at our seminars, in-house training and eLearning.

Who do we need to audit for you?

Outsource your audit to PCS, we usually respond within the hour!

We audit worldwide
Over 550 audits performed since 2010
We usually respond to urgent audit requests within the hour
We take care of the entire audit process

Contact us

We have the expertise and experience to perform your GxP audits worldwide!

Julian Koster
Julian Koster

Director of Business

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

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