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Our Clients

Improving quality and compliance worldwide

Our vision is to seamlessly integrate quality into the very DNA of our clients, enabling them to attain maturity in quality management.

“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
Pharmaceutical capsules exiting a piece of equipment
Bharat Biotech
Boehringer Ingelheim
Daiichi Sankyo
United Nations Industrial Development Organization (UNIDO)
Sandoz Biopharmaceuticals
MSD Pharmaceuticals

People, Patient, Process

Why do our clients choose us?

At PCS, we are more than a consultancy; we are your partners in weaving quality into the fabric of your business. Our team comprises former EU GMP and GDP inspectors, offering unparalleled regulatory insight that keeps us at the forefront of quality solutions. Unlike typical consultancies that focus on individual quality elements, our philosophy is to elevate your organization as a whole. This holistic approach aims to not just tweak but transform, ensuring that quality and compliance are not mere facets but fundamentals of your operations.

We pride ourselves on Dutch directness—a forthrightness that may challenge the status quo but ultimately safeguards your products, compliance, and most importantly, patient safety. Our founders, ex-regulatory inspectors themselves, have ingrained a culture of integrity and exacting standards into our core.

From the Netherlands, our global outreach carries this ethos to international projects, delivering not just advice but actionable strategies that resonate with our slogan, "Sharing the Purpose of Quality." We pair seasoned senior consultants with dynamic juniors, all under the vigilant oversight of our ex-regulatory inspectorate team.

Choosing PCS means opting for a company that champions "People, Patient, Process," and understands the intricacies of the pharmaceutical industry like no other. Whether it's EU GMP, WHO, U.S. FDA GMP, or various international guidelines, our expertise is as broad as it is deep. Entrust us with your quality challenges, and let us guide you towards a future where confidence in your product and business is not just an aspiration but a reality.

Bharat Biotech

Supporting WHO GMP prequalification

“Collaborating with Bharat, PCS refined the pharmaceutical quality system (PQS) and facilitated GMP-related communications with authorities. Our support encompassed GMP adherence, compliance, equipment and facility upgrades consultation. Additionally, we aided Bharat through mock audits, the development of a new aseptic filling line, and risk assessments for the polio production process.”

Solvay Pharmaceuticals

FDA inspection readiness mock-audit & consultancy.

“For Solvay Pharmaceuticals in Germany, PCS conducted a comprehensive two-day consultancy assignment focused on preparing the quality management system for FDA inspections.”

Recent projects

We have worked with hundreds of companies in pharma and biotech.

GMP Consultancy & GMP Audit Services

For Abbott Germany, PCS completed a number of audits (GMP/GCP) and provided GMP consultancy on a number of GMP topics for a number of years. The audits were conducted in Switzerland and Germany, three QC labs and one...

Abbott GmbH & Co. KG | Germany
GMP Consultancy

GMP Consultancy for Vaccine Facility Startup

For Acambis, PCS provided on site technical support for the commissioning, start up and production of Vaccinia vaccine at a facility of Acambis.

Acambis | United States
GMP Consultancy

Auditing Assignment of Production Facilities

A GMP mock-audit was conducted at Acino AG which included manufacturing, CMO's, API sourcing, self inspection, tour of the laboratory facilities and the general QMS.

Acino AG | Germany
GMP Audit

GMP Engineering Consultancy

PCS has advised Airpac Exports on a number of items, including (but not limited to); design development, audits of plant layouts, validation protocol review, GMP construction management, EU product registration and ot...

Airpac Exports | India
GMP Consultancy

GMP Audit Services

PCS has executed a three day GMP audit for Alfasan, the Netherlands. The audit included general GMP items. Alfasan is a Dutch manufacturer of veterinary products.

Alcomed-Alfasan | Netherlands
GMP Audit

Training Program on GMPs in Development

PCS provided a GMP training program for products under development for Alkermes, United States.

Alkermes | United States
GMP Training

GMP Audit

PCS carried out an inventory of the workflows, processes within and between production and quality control at Allergopharma in Reinbek. The aim of the inventory was to determine the required effort and the need for qu...

Allergopharma J. Ganzer KG | Germany
GMP Audit

GMP Auditing Assignment

PCS has conducted a number of GMP Audit worldwide for Amarin. These GMP Audit were conducted in Japan (API suppliers), Nisshin Pharma, Ueda and Bizen Chemical Co, Okayama

Amarin Pharma, Inc. | the United States of America
GMP Audit

Consulting Amaxa in filing a Drug Master File to the FDA

PCS provided general consultancy support for the preparation of a US Drug Master File type II for a product of Amaxa GmbH

Amaxa GmbH | Germany
GMP Consultancy

GMP Training on Aseptic Production

A training was done by PCS at Animal Sciences Group, the Netherlands. The training; Critical Factors for Aseptic Production had a duration of two days. Subjects included; micro-organisms, aseptic production, qualifica...

Animal Sciences Group | Netherlands
GMP Training