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.”
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.
- Founded
- 1990
- Projects
- 260+
- Audits
- 500+
- Trainees
- 10,000+
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.”
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.
Consultancy support to assist in performing GMP compliance audits
PCS has performed over 200 supplier audits for Novartis Pharma over the past years. These audits included API's, sterile and non-sterile finished products, intermediates and excipients on GMP.
Design review and process validation advice for a new purification and fermentation facility
PCS has provided strategic guidance on the process validation programme which included the VMP, cell culture activities, purification processes and virus inactivation processes. As well as a detailed design review aga...
Quality Assurance Support
Quality assurance support to implement a pharmaceutical quality system at Solvay.
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.
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
GMP Auditing Assignment
For Banner Pharmacaps, PCS conducted an IMP audit including the procedures and facilities for the manufacture and release of IMPs as well as to provide advice on current requirements with respect to IMPs. Additional s...
Good Manufacturing Practices Training
PCS organized a two-day GMP training at Banner Pharmacaps including essential Quality System elements such as validation & qualification, batch processing records and deviations for about 15 employees.
Quality Control Support
WHO was informed of a quality complaint concerning lot no. D2076 of Td (tetanus-adult diphtheria vaccine) produced at BB-NCIPD, Ltd, Sofia, Bulgaria and distributed by Intervax. The complaint related to the presence o...
Quality Assurance Support in Pursual of WHO Prequalification
Following a WHO prequalification audit of Bharat Biotech Limited it was decided that GMP QA support was required by PCS. In coordination with Bharat PCS executed the following activities after conducting a preliminary...
Technical Services - IQ, OQ, PQ Assistance
PCS provided continuous on-site presence of 1 Technical Officer assisting Biological E. staff in various IQ, OQ and PQ activities associated with the start-up of the refurbished bulk Tetanus manufacturing facility at...