Certificates

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 III (EG Nr. 1221/2009)
Eco-Management and Audit Scheme

Certificate english

 

ISO 14001
Environmental Management System

Certificate english

 

AEO
Certificate german


 

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