GMP - About PCS

Your guide to
GxP ComplianceRegulatory ComplianceHuman Error ReductionWHO PrequalificationQMS UpgradeGMP Repair

PCS was founded in 1990 with one simple mission: help companies struggling with GMP in achieving regulatory compliance. We have maintained this philosophy throughout the years. Our team consists of experienced, enthousiastic experts who share a common goal of making GMP easy to implement, maintain and comprehend. This allows us to think, operate and be different from other organizations.

Consulting , Training, Auditing, Interim-Management, QA Services, Qualified Persons, Responsible Persons, and More...

We Connect People to Quality

We believe paper compliance is a thing of the past. Only by connecting people to quality will you increase compliance and decrease batch rejections.

PCS is one of the most experienced consultancy organizations on Quality Assurance in the pharmaceutical industry. Contrary to the old fashioned solution of hiring more personnel and increasing the amount of documentation, PCS combines Quality Assurance and Quality Culture to encourage process-ownership and increase efficiency.

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Experienced Professionals

PCS can provide seasoned experts to tackle any GMP/GDP/GLP-related issue you may be encountering. With twenty-six years of experience in the pharmaceutical industry we have dealt with a myriad of situations, problems and challenges. You can view our recent experience here. Our experts can offer a range of services from reviewing existing documentation to creating entire Quality Management Systems.

Areas of Expertise

Our consultants are experts in the fields of Good Manufacturing Practices, Good Distribution Practices, Good Laboratory Practices and current Good control Laboratory Practices for producers of Finished Products, Intermediates, Excipients and Active Pharmaceutical Ingredients.

What Makes PCS Different

PCS is not a recruiment agency but rather a true consultancy company.

At PCS we have developed a unique approach over the years. We always take complete ownership of every project. Resources are pooled, knowledge is shared internally and there is sufficient experience to tackle any problem that may arise during the assignment. We also appoint a senior consultant as project manager without billing extra hours. This way you are ensured that the project will be completed in a proper, timely and cost-effective manner.

See how it works

Recent Projects

PCS always upholds high ethical standards and will not disclose any of our client's information unless they are a public institution, not-for-profit organizations or have given PCS permission to do so. The projects listed below do not display the full range of services PCS offers.

PCS - UNIDO Assessment of Zimbabwean Pharma Industry

PCS and UNIDO have recently completed the audit of a number of Zimbabwean pharmaceutical production companies. The audits were aimed at assessing the Zimbabwean companies against the 17 key-GMP elements that are defined in the TRS's of the WHO. In addition a plan was drawn up to assess the required investments for upgrading to a WHO level industry. The overall report of the assessment can be downloaded here.

Implementation of a QMS for a Herbal Medicine Company

PCS is implementing a Quality Management System (QMS) for a herbal medicine company in the Netherlands. The project includes the creation of a solid QA department, installing and maintaining GMP awareness, computerized systems validation for a Production Management System and preparing the company for a regulatory inspection by the Dutch Healthcare Inspectorate (IGZ) and the Federal Drug Administration (FDA). The client is also preparing to build an additional plant in the Netherlands for which PCS has taken on the project management, QMS implementation as well as delivering a interim-QA Manager to implement the principles of Quality Assurance at the new factory.

DCVMN Kunming Workshop

PCS has delivered a key-note speaker to the DCVMN Kunming Workshop in China on March 17th of 2016. A large number of Chinese delegates were attending the training.

GDP Upgrade and Inspection Readiness

PCS has helped a Dutch manufacturer of radiopharmaceuticals in upgrading the level of GDP within the company as well as sucessfully preparing them for an inspection by the Dutch Healthcare Inspectorate (IGZ).

Responsible Person Services

PCS is providing RP services to a Dutch broker.

Interim Head of Global QA For Indian Vaccine Producers

PCS is an interim Head Global QA for two of India's largest vaccine and oncology medicine manufacturers. The companies have both been WHO-qualified as a result of PCS' GMP-repair efforts.


Our Team

Meet our great team of speakers, consultants, associates and support staff! Together they ensure PCS stays the way it is; a dynamic group of enthousiastic experts working to make your life easier.

Jaap Koster

CEO, Senior Consultant

"Jaap has 33 years of experience, based in various positions (including auditing and training) within (pharmaceutical -and food-) operations in USA, Asia and Europe in bulk chemicals, (aseptic) biologics and packaging."

"GMP, Training, Crisis Management, Auditor"

Specifics

He has performed many vendor/third party audits on contract basis. Projects involved Auditing, Quality (Systems), Validation, Operations, Engineering, Project Management (including BSL-3 and aseptic Cleanrooms), Logistics and cultural turn-a rounds.

Jos Brinkhuis

Microbiology, Trainer, Consultant

"Jos is an expert in microbiology and GMP. He possesses an analytical mindset and is well-experienced with GMP, WHO and other regulatory guidelines."

"WHO, GMP, QC, Quality Culture"

Specifics

He is an expert on regulatory guidances and Quality Control. He has a rich experience in a number of companies including ISO 9001. Jos is also a trainer for the GMP courses organized by PCS both in-house and hotel seminars.

Karen Zimmermann

GMP, GDP, Training, Coach

"Karen Zimmermann is a GMP/GDP consultant and trainer at PCS. She has worked in several managerial Quality positions for Biotech and Pharmaceutical companies. "

"GMP, GDP, Training, Teamwork"

Specifics

She strongly believes Quality depends on knowledge, accountability and teamwork. Karen’s expertise focuses on GMP, GDP, QA, Management, Training and Leadership & Teamwork Development. She has supported a great number of companies in recent years achieving a greater level of quality by integrating the principles of quality culture.

Hans Meerburg

GMP, GDP, Training

"Hans Meerburg is an experienced pharmacist who started working at one three days after graduating in 1980. He has held a large number of positions as Quality Manager, QP and now has his own consultancy firm."

"GMP, Pharmacist, Training, QP"

Specifics

Hans has numerous years of experience, amongst which owning his own pharmacy. Lately he has been focusing on helping smaller companies within the Netherlands grow whilst providing training at PCS' seminars and courses. In addition to this he is a interim consultant at some of the larger companies in the Netherlands.

René Maassen

GMP, GDP, Training

"René Maassen started his career at Solvay Pharmaceuticals, after being Head QA he became Senior Inspector GMP/GDP at the Dutch Healthcare Inspectorate (IGZ), he was director at PCS between 2003 and 2013."

"GMP, Pharmacist, Training, QP"

Specifics

René is a highly skilled and experienced consultant, with experience as an inspector he can apply his wealth of knowledge to his activities as a consultant. He is also one of the key speakers at the training courses of PCS.

Rajendra Vidwans

GMP, WHO, India, Training

"Rajendra Vidwans is Director of PCS India and has over 38 years of experience in several QA departments of renowned Indian multinationals. In his long career, Rajendra has gained extensive knowledge of the WHO and GMP."

"Director PCS India"

Specifics

He is the director of PCS India and has his own consultancy business in India where he serves many of India's largest manufacturers. Rajendra is a speaker for PCS training in India as well as any worldwide seminars.

Sudhir Phatak

GMP, WHO, Audits

"Sudhir Phatak is a representative of PCS in India, he has his own consultancy firm; Futurol Enterprises and helps several Indian companies with QMS implementation, WHO regulatory affairs and QA-related assignments."

"GMP, WHO, Audits"

Specifics

He started his career working in QA and has since held the positions of QA Manager at several reputable companies within India. In short; GMP Consultant: QMS Designing, Qualifications & Validations, Layout Designing, Audits, Compliance Support and Trainings.

Yash Karkhanis

HVAC, Formulation, Capsule

"Yash Karkhanis has over 23 years of experience with capsule manufacturing (gelatin & non-gelatin) and formulation manufacturing (solid-oral dosages). Has guided many products from design- up to the market."

"HVAC, Formulation, Capsule"

Specifics

He has worked in many senior management positions and is an expert on the Application & Development of new products and technologies. He has an expertise in HVAC systems, Energy Conservation, SCADA development, Condition Monitoring, Automatic Gauging, Special Purpose Equipments & automation.

Deepak Gudhate

GMP, Quality Assurance

"Deepak Gudhate is a highly competent professional with over 23 years of rich experience in Quality Assurance, Quality Control, Regulatory and QA projects within the (Indian) pharmaceutical sector."

"Pharmacist, Quality Assurance"

Specifics

Deepak is a strong teamplayer and has established himself as a SME on Quality Assurance within India. In addition, he has extensive knowledge of solid dosage forms, including tablets, capsules, liquid orals and powders.

Belinda Rozenhart

Auditor, GMP, Trainer

"She has more than 25 years of experience in over 20 different companies in the bio(pharmaceutical)-industry. In those years she grew from manufacturing pharmacist to all round Qualified Person."

"Quality Culture, Qualified Person, GMP"

Specifics

She has more than 25 years of experience in over 20 different companies in the bio(pharmaceutical)-industry. In those years she grew from manufacturing pharmacist to all round Qualified Person & Quality Management Systems specialist. A few years ago she graduated also as Job- & Life Coach. She is a ISO 13485 Lead Auditor.

Arjen Raavé

Engineer

"Arjen has a long and international experience in initializing and realizing multi-disciplinary projects in the following fields: Pharmaceuticals, High end food and Special chemicals."

"GMP, Engineering, Food and Chemicals"

Specifics

He has a broad experience in all engineering disciplines. (Process, mechanical, I&E, process-control and civil) in all its defined project phases which includes, conceptual design, EPC, commissioning, qualification, validation and project handover.

Emily Harks

Training Coordinator

"Emily was responsible for the training program in the Netherlands for one of the leading brands in dermatology. She is new to the pharmaceutical sector and very excited to specialize in another line of work. "

"Training Point of Contact"

Specifics

She is experienced in organizing training, workshops and events for large groups of dermatologists, plastic surgeons, estheticians & patients. Emily is Training Coordinator at PCS, responsible for all in-house training and seminars. She may be contacted for any training-related matters at: emily.harks@pcs-nl.com.

Julian Koster

Director of Business

"Over 11 years of experience with the ins- and outs of the pharmaceutical and business industry. This combination allows Julian to assess and subsequently change practical problems without hesitation."

"GMP, GDP, Business Development"

Specifics

Julian is the Director of Business at PCS. As such, he is our first point of contact for any inquiries. An analytical mindset has allowed him to explore Computerized Systems Validation (CSV) from the EU GMP and GAMP 5 perspective and implement this knowledge in the pharmaceutical industry.

Dr. Bilquis Yasmeen

Director PCS Pakistan

"Bilquis Yasmeen is an experienced trainer and consultant in the areas of Quality Management Systems, Functional Baseline, Lean Sigma process matrix, Process /system development & Leadership."

"GMP Consultant & Trainer"

Specifics

Dr. Yasmeen worked in GSK for sixteen years in various business roles & has versatile professional experience and leadership in Operational Excellence and Organizational Development. She is a director at PCS Pakistan.

Ashiq Hussain

Director PCS Pakistan

"A seasoned and experienced persons having 30 years plus experience in Supply Chain, Materials Management and Planning in GSK Pakistan, alongwtih hands on experience of Industrial, Manufacturing and Mechanical Engineering."

"GMP & GDP Consultant"

Specifics

Worked closely with Quality, Production and R & D department for Vendor Development, Vendor Audits, Product and materials development for Pharma Industries. Certified Green Belt for Lean Sigma. Ashiq is a Director of PCS Pakistan.

Alda Maayen

Finance Head

"Alda is responsible for all financial matters at PCS. She has a background in bookkeeping and accounting. She holds a Master of Laws (LLM) degree, specializing in Fiscal Law."

"Finance, Bookkeeping, Accounting"

Specifics

Alda is responsible for all financial matters at PCS. She has a background in bookkeeping and accounting. She holds a Master of Laws (LLM) degree, specializing in Fiscal Law. Besides her work at PCS, Alda has her own financial advice firm; "Administratiekantoor Alda Maayen".

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