The company provides tailored support in projects concerning establishing and developing quality systems, assessing and auditing suppliers and contractors, and training of personnel. Background for expertise is wide and variable experience in assessments and inspections of development and production of pharmaceuticals and healthcare organisations and laboratories.
Internal audits, supplier and contractor audits, inspections.
Consulting and support in establishing and developing quality system.
Training tailored specifically for the clients needs.
More than 20 years’ experience in inspections, assessments and evaluations by national and international authorities (FINAS, Fimea, EMA, WHO, EFSA, OECD)
GLP, GMP, ATMP-GMP, GDP, ISO 13485, ISO 15189, ISO 17025, ISO 9001, EU Directives for Tissue Establishments