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GMP Consultancy Services for the Pharmaceutical Industry

At PCS, we specialize in providing expert Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) consultancy services.

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Why you should choose PCS for your consultancy needs

  • Over 30 years of GMP & GDP experience and expertise
  • Team of regulatory and industry professionals
  • We know what the government expects and inspects
  • EU GxP, U.S. FDA and WHO GMP expertise

Looking for a partner in GMP?

PCS helps it's clients meet quality and regulatory requirements. We do this by training, advising and continuously checking your compliance level. Thereby guaranteeing that your company meets the GMP rules and regulations.

What is GMP?

Good Manufacturing Practice, also known by its common abbreviation "GMP", is a quality assurance system for the pharmaceutical industry. Only a carefully defined and controlled production process ensures the quality of a medicine.

Without a GMP license, also known as a "MIA" or Manufacturing and Import Authorization, drug manufacturers are not allowed to sell their products to pharmacies or hospital pharmacies.

Why choose PCS for GMP advice and training?

PCS helps clients to achieve the desired level of quality. We do this by providing GMP training. In addition, we can also be called in for GMP consultancy and we help you with the application for GMP licenses.

Our services range from implementation of quality systems, obtaining GMP licenses to interim management and training. Our approach is simple: understanding and mastering your process is key to GMP.

Supply chains are very complex, the quality department often has a full-time job keeping the quality system up-to-date and production struggles to meet demand. PCS comes to the rescue to ensure that everything goes according to the right guidelines.

Customers choose PCS because of our extensive regulatory experience. Time always plays a role in our projects. We know how the authorities work and what they expect. In this way we bring our clients to a higher level of GMP compliance efficiently, within time and within budget. Thanks to our team of passionate consultants, consisting of ex-EU GMP inspectors and leading industry experts, we can provide this unique service to the pharmaceutical market.

Our clients

Pharmaceutical companies choose the GMP services of PCS for their quality, construction or inspection preparation projects.

A few of our GMP projects:

  • Transgene TUP Strasbourg Design, project support and start-up services for a GMP factory.

  • Boehringer Ingelheim Long-term GMP support for Boehringer Ingelheim.

  • Solvay GMP quality system support for Solvay, Germany.

Jaap Koster, CEO of PCS, avatar

Effective GMP consultancy is the cornerstone of pharmaceutical excellence, safeguarding product integrity and patient safety at every step.

Eng. J.J.M. Koster

GMP consultancy

Maintaining or upgrading GMP is a challenge. You will not achieve it with quick fixes. Fundamental solutions are needed, starting at the core of your business. Knowing what you produce, why you produce it and what your critical process parameters are leads to immediate improvement.Our experienced GMP consultants dive into your company and give advice on everything related to GMP.

Our team consists of experienced consulates and ex-government inspectors who know exactly what the government wants to see. This allows projects to be handled faster and more accurately.In addition, PCS has very diverse and especially worldwide experience. This international experience enables us to tackle the more difficult projects; doing business internationally makes flexibility a necessity.

MIA license

But its not just the complex problems we solve. If you need a Manufacturing and Import license, we will help you obtain it. From audits to equipment qualification - up to filing the license and receiving the inspection, its all handled by our team of industry and regulatory experts.

GMP training

If you need a simple GMP training, we can help. We have a wide range of GMP training courses that can be organized as a seminar or in-house covering a wide range of topics from operator training to quality culture implementation. We provide in-house training, seminars and online courses.The GMP training courses are divided into three levels;

  • Beginner

  • Intermediate

  • Professional

Are you a beginner in the pharmaceutical industry? Then we offer the GMP training for beginners. These trainings provide a solid foundation for participants new to GMP regulatory requirements. No experience in GMPs or the pharmaceutical industry as a whole is required for the GMP beginner training.

GMP intermediate level courses can be taken with a basic understanding of GMP regulations and some experience in the pharmaceutical industry.

They are designed to provide a high level explanation to the public about the essential GMP elements such as the quality system, personnel qualification and equipment qualification for example.

If you want to follow a GMP training at a professional level, the participants are expected to have a solid knowledge of the GMP regulations. These trainings are designed to provide participants with advanced knowledge on complex topics in the pharmaceutical and biotechnology industry.

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Frequently asked questions

What Sets PCS' GMP Training Apart?

- 31 jaar GMP- en GDP-trainingservaring - Meer dan 10.000 studenten hebben met succes een PCS GMP- of GDP-trainingscertificaat behaald - Deskundige docenten uit de industrie en regelgevende instanties - Bewezen didactische methoden die uw kennisbehoud optimaliseren - Cursussen worden elk jaar bijgewerkt, waarbij de nieuwste GMP- of GDP-ontwikkelingen en industriestandaarden worden geïmplementeerd - Onze trainingscertificaten worden algemeen aanvaard - Veel interactieve workshops waarmee u de theorie in de praktijk kunt brengen

Why is Good GMP Consultancy Crucial in the Pharmaceutical Industry?

Effective GMP consultancy is pivotal in ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. It is fundamental in safeguarding product integrity and patient safety, which are paramount in the pharmaceutical industry.

What Risks Are Mitigated Through GMP Consultancy?

GMP consultancy helps in identifying and mitigating risks such as cross-contamination, incorrect labeling, and inadequate storage, which are critical to maintaining the highest standards of pharmaceutical product quality and safety.

Can GMP Consultancy Aid in Regulatory Compliance?

Absolutely. GMP consultancy plays a crucial role in ensuring that pharmaceutical companies not only meet but exceed regulatory requirements, thereby avoiding legal issues and enhancing market reputation.

What Are the Long-term Benefits of Investing in GMP Consultancy?

Investing in GMP consultancy leads to long-term benefits such as sustained compliance, enhanced operational efficiency, improved product quality, and a stronger market position.

Let's get started!

We are a pharmaceutical consultancy dedicated to quality and patient safety. Do you want to solve a quality or regulatory problem, are you looking for a GMP license or good GMP training? We have the expertise and experience to solve it. Feel free to contact us if you have any questions about services or GMP in general.

  • Over 30 years of GMP & GDP experience and expertise
  • Team of regulatory and industry professionals
  • We know what the government expects and inspects
  • EU GxP, U.S. FDA and WHO GMP expertise