Our clients

Interim Corporate Quality Assurance

PCS has lead the Corporate Quality Assurance Department of PanEra on Ad Interim basis as part of the Quality Management Organ... more information

Mock FDA Pre-Approval Inspection

Eurand had asked PCS to perform the second part of a mock FDA Pre Approval-type inspection on the manufacture and control ope... more information

GMP Consultancy

PCS provided consultancy support to review and design a suitable logistic system for raw material and general supplies manage... more information

GMP Consultancy for Sterile Production

PCS was contacted by Merck Sante to assess the US FDA compliance status of a sterile production process. Merck Santé S.A.S. i... more information

GMP Qualification Support

PCS conducted an assessment of the qualification status of critical GMP equipment at Organon, the Netherlands. The equipment... more information

Executing a GLP Audit on behalf of the LUMC

The Leiden University Medical Center (LUMC) contracted PCS to audit one of its suppliers against Good Laboratory Practice (GL... more information

GMP Construction Management & Manufacturing Support

To aid FAP Brazil construct a GMP facility in Brazil, PCS has offered engineering and consultancy services. This included (am... more information

Good Manufacturing Practices Training

PCS organized a two-day GMP training at Banner Pharmacaps including essential Quality System elements such as validation & q... more information

Investigational Medicinal Product (IMP) Assessment

PCS was contracted to provide consultation services with regards to performance of audits based on European GMPs and provide... more information

FDA Inspection Readiness Training

PCS provided a two-day training on FDA inspection readiness. Topics included; the regulatory background to FDA inspections an... more information

GMP Consultancy for a New Facility

PCS advised Medac on a number of GMP items for a new facility of Medac. Services included; design review, supplier qualificat... more information

GMP Advanced Training

PCS organized a in-house training on Advanced Aspects of GMP for Mallinckrodt Baker. The training included topics such as; Th... more information

GMP Introduction Training & Practical Support

PCS has provided the packaging organization CurTec International with practical consultancy advice on GMP packaging matters a... more information

GMP Audit

PCS conducted a GMP audit of a support of GenIbet, Portugal. The audit was conducted in Europe and had a primary focus on Qua... more information

GMP Audit of Zimbabwean Pharma Industry

PCS and UNIDO have recently completed the audit of a number of Zimbabwean pharmaceutical production companies. The audits wer... more information

Consultancy Support during the Design, Construction, Commissioning and Operation of new Vaccine Manufacturing and Filling Facilities in India

For Indian Immunologicals Ltd in India, PCS assisted in the review of drawings, construction management, SOP/STP review as we... more information

WHO Prequalification Audit

PCS performed a WHO Pre Qualification audit for Yuxi Walvax Biotechnology. Yuxi Walvax is a modern biological pharmaceutical... more information

GMP Packaging Consultancy

PCS assisted and supported Budelpack staff in bringing the GMP packaging facilities into compliance with current regulatory e... more information

GMP Audit

PCS conducted three GMP audits on finished products and API's for the U.S. market.

Cleanroom reconstruction consultancy

In connection with the new construction / renovation of a cleanroom at Dopharma, PCS advised the internal project team during... more information

GMP Auditing Assignment

PCS performed three GMP Audit for BioVecta, Canada. The three companies that were audited were located in China and were audi... more information

GMP Consultancy

PCS has assisted SAHZ in writing several User Requirement Specifications (URS) for technical installations, including a pharm... more information

GMP Update Training

To supply an in-house training to CAF-DCF on EU/FDA regulatory guideline updates, Annex 14 on the Manufacture of Products der... more information

Interim Corporate Quality Assurance

PCS has lead the Corporate Quality Assurance Department of Panacea on Ad Interim basis as part of the Quality Management Orga... more information

GMP Training Validation of Production Processes

PCS organized in-house training for FAMAR, the Netherlands. The training focuses on the validation of production processes. T... more information

GMP Consultancy

Bharat was attempting to obtain European approval as a manufacturing site for Propopoval Injection, an intravenous oil in wat... more information

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 c... more information

GMP Production, QA and QC Support

For Fort Dodge, PCS has provided GMP consultancy services, assigning a consultant to assist Fort Dodge with Quality Assurance... more information

GMP Audit of Critical Supplier

PCS conducted a two-day GMP audit of a critical supplier of Medtronic. PCS was asked to ascertain compliance with current Goo... more information

Cleaning Validation Support & Consultancy for a new PD facility

To perform an assessment of the status of the current cleaning validation at Crucell Switzerland AG, in the light of an upcom... more information

GMP Audit Services

To provide a qualified assessment to Baxter AG on the standards of GMP that were in place at North American Vaccine Inc.

GMP Training and GMP Consultancy

For Astellas and Yamanouchi, PCS conducted a number of services over the years such as GMP Document Management Consultancy, i... more information

GMP Audit Services

PCS conducted a full GMP audit to MCA/EU standards of the manufacturing facilities associated with Lotemax in preparation for... more information

GMP for Hospitals Audit

To establish the current level of GMP-Z at the Ziekenhuisapotheek Medisch Centrum Leeuwarden. The GMP-Z is a special GMP cate... more information

WHO Prequalification Audit

In 2007, PCS has performed an assessment concerning the GMP readiness for WHO prequalification of a vaccine that Sinovac Biot... more information

Self Inspection Performance

PCS performed regular self inspections of various operatioanl departments to ensure continued compliance to GMP. PCS also ass... more information

GMP Audit

For Mallinckrodt Baker PCS performed a GMP audit of the salt production and water production facilities. The audit was comple... more information

GDP Compliance Inspection & On-Site Training

The Institute of Physical Safety (Instituut Fysieke Veiligheid) is a Dutch nongovernmental organization which coordinates wit... more information

FDA GMP Readiness Assessment

PCS assisted Glaxo to determine the degree of compliance to current US GMPs (cGMP) (FDA) for the manufacture of finished phar... more information

GMP Consultancy for FDA Audit

For Solvay Pharmaceuticals, Germany PCS organized a two day consultancy assignment which covered FDA inspection preparation o... more information

GMP Pre-Inspection Audit (FDA)

PCS performed a pre-inspection audit Protein Sciences was to receive by the U.S. FDA

Quality Control Support

WHO was informed of a quality complaint concerning lot no. D2076 of Td (tetanus-adult diphtheria vaccine) produced at BB-NCIP... more information

WHO GMP for Vaccines Implementation

PCS helped Sovereign Pharma complete the introduction of a new vaccine according to WHO GMP standards.

GMP Consultancy and WHO Audit Response

For Biofarma Indonesia, PCS was contracted to perform GMP consultancy following a WHO GMP audit of it's manufacturing facilit... more information

GMP Remediation Assessment

PCS has helped FAMAR in Spain respond to a client audit with a number of GMP related CAPA's as well as training.

GMP Qualification Audits of Suppliers

For Quark Pharmaceuticals, PCS conducted a number of GMP audits. One of the audits involved a German manufacturer of an API f... more information

EU GMP Audit of the Bulk Fractionation Facility

For NABI, PCS performed a GMP audit of the Bulk Fractionation facility, to assess premises and quality systems relative... more information

GMP Consultancy & GMP Audit

Several GMP audits were performed for Boehringer Ingelheim, Netherlands. Additional services included the assessment of Quali... more information

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... more information

GMP Training on Aseptic Production

A training was done by PCS at Animal Sciences Group, the Netherlands. The training; Critical Factors for Aseptic Production h... more information

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 n... more information

WHO GMP Audit

PCS performed a full GMP audit to WHO standards of the manufacturing and control activities associated with the production of... more information

Good Distribution Practice GDP Training

For Schuitema, Netherlands, PCS organized a GDP training for the entire organization, including its truck drivers and quality... more information

GMP for Pilot Plan

PCS provided support and consultancy for a project designed to implement Good Manufacturing Practices in a pilot plant intend... more information

Training Program on GMPs in Development

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

Project Support for the implementation of a Quality Management System (QMS) for the Manufacturing and Supply (M&S) division

Together with Norgine corporate quality, PCS has implemented a QMS for Norgine's Manufacturing & Supply business unit. This Q... more information

GMP Services for a new GMP Factory

For DMV International, PCS provided consultancy services that aimed at training on validation and the execution of validation... more information

Pre Approval Inspection Consultancy

Celltrion, Inc. (Celltrion), a biopharmaceutical contract manufacturer located near Seoul, Korea, required consulting assista... more information

Pharmaceutical Legislation Training

A pharmaceutical legislation training was provided to Meda Pharma of six hours in duration. The training focused on European... more information

GMP Engineering & Consultancy for New Fermentation and Purification Facility

PCS assisted Praecis with a detailed design review of the proposed new fermentation and purification facilities for MDCK-deri... more information

Quality Assurance Support

Quality assurance support to implement a pharmaceutical quality system at Solvay.

GMP Introduction Training

To supply an internal training course to Crucell on the basics of GMP (introduction to GMP). This two-day program focused on... more information

GDP Certification (WDL)

PCS has helped the Dutch/Italian pharma company VISUfarma with the attainment of a Wholesale Distribution Authorization (WDL)... more information

GMP Audit of a Supplier

PCS performed a GMP inspection and general review on the quality systems at an Austrian supplier of Fresenius Kabi.

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

GMP Training on Auditing US FDA and EU GMP Facilities

For Schering SBI, PCS organized a training course on the differences between EU and US (FDA) GMP's; the training focused on a... more information

GMP Training

A training Critical Factors in Aseptic Production was organized in-house at the RadboudUMC university hospital. The training... more information

GMP Inspection of Validation Protocols

Centocor contracted PCS to perform a review of their current systems and procedures surrounding the validation programme. The... more information

GDP Consultancy

For Wyeth, the Netherlands PCS has assisted with all quality related matters for a warehouse under GDP.

GMP Consultancy, GMP Audit and FDA Training

For Roche Diagnostics, PCS has provided a number of services which included FDA training on; Introduction to the FDA, The FDA... more information

Good Manufacturing Practices Training

An inhouse GMP training was organized at GE Healthcare, spanning two days. The training included advanced GMP principles such... more information

GMP Auditing Assignment

PCS has conducted a number of GMP Audit worldwide for Amarin. These GMP Audit were conducted in Japan (API suppliers), Nisshi... more information

GMP Assessment of EU Compliance

PCS performed a preliminary assessment of a product for compliance to EU standards of Good Manufacturing Practice, in particu... more information

GMP Training Services

PCS has provided a training on Good Manufacturing Practices to Dishman Netherlands B.V.

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, puri... more information

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 activi... more information

QP Support and EU GMP Support

PCS provided general QP support as well as GMP advice on the importation and distribution of products to the EU.

EU GMP Inspection

For Cambrex, United States, PCS conducted a three day EU GMP Inspection of it's facilities. The EU cGMP inspection/mock audit... more information

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... more information

WHO GMP for Vaccines Implementation

PCS provided the following services to the Institute of Immunology; GMP upgrade and continues support thereon; achieving the... more information

GMP Audits of API Manufacturer

PCS performed a cGMP audit of the active pharmaceutical ingredients manufacturing area of Roche Bioscience’s site.

Pharmaceutical Quality System Upgrade

To assist in the upgrade of the pharmaceutical quality systems at Meggle associated with the manufacture of inhalation and or... more information

GMP Auditing Assignment and GMP Consultancy

For Roche Italy, PCS has conducted several supplier qualification (third party) audits. Besides the audit services, consultan... more information

GMP Training on FDA Inspections and current Good Manufacturing Practices

Intervet International B.V. (currently MSD Animal Health Nederland) has asked PCS to organize two in-house GMP training cours... more information

Provision of QP Services

PCS has provided Qualified Person (QP) services to Merck Sharp & Dohme as well as GMP consultancy on internal audits, 3rd par... more information

Review of Zoning Concept

Gebro Pharma has asked PCS to review it's zoning concept anticipating a revision of the facilities at Gebro Pharma. Gebro Pha... more information

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 la... more information

GMP Audit

For SmartGenRx, an Australian pharmaceutical company, PCS conducted multiple supplier audits throughout Europe with a focus o... more information

GMP Auditing Assignment

For Banner Pharmacaps, PCS conducted an IMP audit including the procedures and facilities for the manufacture and release of... more information

GMP Development Plan for Recombinant EPO

PCS conducted an in-depth review of; formulations, cell banks, API manufacturing process, API toxicology, stability of finish... more information