From compliance to culture. By design, since 1990.
PCS was founded to shift the industry's emphasis from mere compliance to a more genuine, process-oriented approach to quality. Thirty-five years on, that is still the work: embedding quality into operational DNA so it survives audit, leadership change, and supply-chain stress—not just passes the next inspection.
PCS is founded
Founded to shift the industry's emphasis from mere compliance to a more genuine, process-oriented approach to quality. That founding intent still drives every engagement today.
First training delivered
The first "GMP for Middle Management" cohort runs. The course is still in the calendar today—now in its sixty-seventh edition in 2026.
Jaap Koster joins as CEO
Jaap Koster becomes CEO, deepening the portfolio with hands-on GMP, crisis-management, and process-engineering practice across manufacturing sites in Europe, Asia, and the Americas.
QP postgraduate programme joins PCS
PCS acquires the "Quality Management in Pharma and Biotech" postgraduate programme—the route many Dutch Qualified Persons take into the role. PCS Academy is now where regulators-in-the-making meet regulators-turned-faculty.
The work that earned our reputation
GxP consultancy, independent GMP and GDP audits, interim QPs and QA leadership, and PCS Academy training. Engagements have ranged from single-finding remediations to multi-site quality system overhauls for organisations such as the ones below.
Our mission
Shift quality from compliance bottleneck to operational enabler—so the patient at the end of the chain gets safe medicine, and the manufacturer that made it doesn't rebuild its quality system every inspection cycle.
That is the founding intent of PCS, restated. We embed quality into the very DNA of how a site operates, so the system holds up after we leave. Remediation closes findings root-cause-first, not symptom-first. CAPA backlogs disappear; repeat deviations stop repeating. Inspection readiness earns fewer findings and faster closures. The aim, over a multi-month engagement, is a quality posture that regulators audit once and trust.
European-based consultants who have walked through MHRA, EMA, and FDA playbooks.
Our bench includes a former EMA/IGZ inspector and senior practitioners who have stood on both sides of the inspection table. That perspective is what large-pharma QA directors hire us for: we know what the inspector meant, not just what the SOP says.
500+
Independent GMP and GDP audits delivered
Supplier qualification, mock inspections, gap assessments—across API, finished product, biologicals, and distribution.
1990
10,000+ GxP professionals trained since 1990.
PCS Academy runs GMP, GDP, pharmaceutical quality, and the postgraduate QP programme—taught by practitioners, not slide-readers.
35+
Years building, repairing, and stress-testing pharmaceutical quality systems—through ICH revisions, Annex 1 deadlines, Brexit, and a pandemic. The work changes; the founding intent doesn't.
Who actually does the work
PCS engagements are delivered by named senior consultants—several with prior careers as regulators or inspectors. No bait-and-switch to junior staff after the proposal is signed. If you're evaluating us for a multi-month programme, the consultants page is the right next click.
Engagements worth showing
A few projects from the casework—names anonymised where the work is sensitive.
Example Projects
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- Project Title
- WHO GMP Upgrade
- Description
- After an unsuccessful WHO inspection, Panacea Biotech sought as...
- Client Name
- Panacea Biotec
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- Project Title
- GDP QMS Implementation & Achieving WDA
- Description
- PCS implemented a GDP QMS for a British manufacturer with a Dut...
- Client Name
- Anonymous
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- Project Title
- U.S. FDA Inspection Preparation
- Description
- PCS developed an extensive US FDA inspection preparation progra...
- Client Name
- Anonymous