The core activity of NIPCOS GmbH is to advise and support pharmaceutical and life science companies in the areas of Regulatory Affairs, GxP (Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice, Good Laboratory Practice) and quality management. Specifically, NIPCOS offers services such as technical leadership, registration, licensing, authority inspection, audit, pharmacovigilance and quality assurance.
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Industry:Management Consulting
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Technical leadership on a mandate for companies with Swissmedic operating authorisation, including deputising, negotiations with authorities, quality assurance, market and batch release, inspections, audits and product dossiers.
Regulatory Affairs
Regulatory Affairs for medicines and clinical documents, with registration strategy, marketing authorisation applications, Drug Master Files, documentation, negotiations with authorities, as well as maintenance and renewal of authorisations.
GMP / GDP / GCP / GLP / Quality Management
Advisory services on GMP, GDP, GCP and GLP as well as quality management, including implementation and maintenance of QMS systems, regulatory inspections, internal and external audits, supplier management and training.
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