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Quality posture that survives audit, leadership change, and supply-chain stress.

If you're a QA leader past the checkbox-compliance stage, you're in the right place. PCS embeds quality into operational DNA: remediation that closes findings root-cause-first, inspection readiness that earns fewer findings and faster closures, and interim QPs who release batches day one. Our approach has been built over 35 years and is informed by ex-EMA and PIC/S inspectors in our team.

Ex-EMA inspector on the bench 500+ GMP & GDP audits delivered 10,000+ professionals trained since 1990 Netherlands-based; engagements across EU, UK, US, and global markets
Consultancy Scope an engagement See client casework
PCS Academy Browse the training calendar GMP, GDP, QP postgraduate programmes
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Smiling woman in front of glass wall, writing on post-its
Green medicine capsules on blistering conveyor belt
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Retained by global manufacturers, vaccine producers, and distributors—including:

Abbott Merck Sharp Dohme Roche Sinovac

Where you are right now

Pick the moment that matches yours. Each page sets out the typical scope, deliverables, and timeline—written for QA leaders, not procurement decks.

Inspection readiness & remediation

A 483, an MHRA critical, or an EMA notice on the desk. We triage findings, close them root-cause-first, and rehearse the re-inspection.

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QMS / PQS maturity

ICH Q10 in name, but the system bottlenecks production and confuses inspectors. We refit it around ICH Q9(R1) risk thinking and the way your site actually runs.

See deliverables

Quality culture & human performance

Repeat deviations, undocumented workarounds, an inspector flagging culture. We shift quality from compliance bottleneck to operational enabler—and make it stick after we leave.

Explore approach

Manufacturing & operational excellence (GxP)

Aseptic process simulations, CCS under Annex 1 scrutiny, OEE that stalls because quality and operations argue. We close the gap between shopfloor execution and PQS oversight.

See typical outcomes

CAPA & deviation effectiveness

CAPA backlogs disappear; repeat deviations stop repeating. Stronger investigations, root-cause-first closures, and effectiveness checks that hold up at the next inspection.

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Interim leadership (QA / QP / RP)

Sole QP resigned, batch release at risk, or QA director seat empty mid-inspection cycle. We place senior interims who release batches day one and transfer knowledge day final.

See engagement options

Scope an engagement See client casework Or training instead? View the PCS Academy calendar

Upcoming trainings

Next dates you can join

Four upcoming sessions across GMP/GDP topics. Reserve a seat before they fill up.

View training calendar
Data Integrity image
Good Manufacturing Practice (GMP) | GMP Training

Data Integrity

One-day training on implementing and adhering to Data Integrity and the importance of Quality Culture.

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GMP and GDP Combined

Change Control

From A-to-B, whilst being in-control, from a GMP perspective.

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Doctor drawing vaccine from vial on a blue background

PCS is one of the best consulting services we had ever worked with regarding WHO Prequalification mock on-site inspection, GMP consultancy, cGMP training as well as CAPA planning.

Neal Xiao
Yuxi Walvax Biotechnology
Logo Dawa Life Sciences in dark-grey on transparent background.

“The statement by PCS that QMS' are often too much driven by QA is correct and will help to change mindset. PCS have a good understanding of the conditions within a developing country which is important.”

Dr. Frank Hoffman
Dawa Life Sciences
Shandong Xinhua Europe Logo

“I would recommend the solutions PCS offers because of the good quality, service and excellent communication.”

W. Pot
Shandong Xinhua Europe

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