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In regular audits, independent experts confirm that we are applying the relevant standards, laws and guidelines. Our integrated management system is certificated according to many standards. The certificates cover development, production and marketing:
GMP WHO guidelines on good manufacturing practice for pharmaceutical products
Manufacturing Authorisation
Certificate Human Medicinal Products
Certificate Human Investigational Medicinal Products for phase I, II, III
Certificate Veterinary Medicinal Products
ISO 9001 Quality Management System
Certificate english
ISO 13485 Quality Assurance System for medical devices
Certificate english
Directive 93/42/EEC Annex II Quality Assurance System (EC declaration of conformity)
Certificate english Certificate french
EMAS II (EG Nr. 761/2001) Eco-Management and Audit Scheme
Certificate english
ISO 14001 Environmental Management System
Certificate english
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