Consultancy Services
PCS offers a comprehensive package of services to assist you in achieving compliance with current Good Manufacturing Practices.
In addition to these standard services, a network of experienced and reliable associates allows PCS to provide a number of specialised services, which include: business consulting, ICT consulting, in-house translation capabilities in French, German, Dutch, English and Spanish, Interim Management, microbiological services, project management, inspections and preparations to regulatory inspections, research and development.
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Self-Inspection & Auditing Current GMPs call for a comprehensive programme of self-inspection and auditing as part of the Quality Management system. PCS will carry out such audits against published GMP guidelines, both as part of pre-inspection preparations or as part of the ongoing self-inspection programme. In addition, PCS will carry out third party audits and inspections of suppliers of starting materials or equipment. |
Quality Assurance
PCS will review, update or advise on QA systems. If necessary, an entire QA concept can be developed; support can be provided for its implementation, maintenance and monitoring.
In particular, PCS are able to assist in the preparation of Quality Assurance handbooks which can be either custom-designed or modelled on the requirements of ISO 9000.
Registration PCS can assist in the Registration process, both with in-house expertise as well as contacts throughout the world. PCS can provide assistance in preparing Drug Master Files, Product Licence Applications, Establishment Licence Applications and Pharmaceutical and Analytical expert reports, for US FDA and European Regulatory requirements. |
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Sterile Production Processes
The partners have significant practical, theoretical and Regulatory experience in the manufacture of sterile pharmaceutical products.
PCS can therefore advise on equipment requirements, environmental matters and personnel training needs for this important class of products.
Validation
Validation continues to make ever-increasing demands upon company resources. PCS will develop validation programmes for all critical pharmaceutical equipment, installations and processes.
Upon request, PCS will supervise the implementation of a validation programme and provide practical support to complete the work in the most cost-effective and timely manner.
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Pharmaceutical Engineering Projects PCS can provide a full service from initial facility design, through project consulting, project management, installation and validation, all to recognised Regulatory requirements. If called upon, PCS can arrange for the purchase, installation and validation of pharmaceutical equipment. |
Documentation
PCS can advise on all aspects of control and manufacturing documentation. This can include the initial planning of a basic documentation system, through to actual preparation of documents required by the client.
PCS are able to supervise and subsequently review the translation of any pharmaceutical documentation in English, German, French, Dutch or Spanish.
Contract Service Evaluation
The use of contract services, either for manufacture or testing, is increasing. Current GMPs place the responsibility for assuring the quality of such activities on the Contract Giver.
PCS will evaluate contractors for compliance to GMP/GCLP and will provide an independent assessment of the quality of the services on offer.
Interim Management & QP Services
PCS has extensive experience in providing interim management and QP services for both multinational and SMB companies, both long term and short term, in various areas of expertise.