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ISO 9001 version 2008 compliance - BVQI
The pharmaceutical development process at Galenix is oriented
towards the customer's needs and comply with European and US FDA standards.
Quality Assurance teams support all activities, assuring that standard
operating procedures are followed and that Good Manufacturing Practices
are implemented throughout the project.
ISO 9001 Version 2008
Certification for Galenix Innovations and Galenix Pharma.
Galenix was First French R&D company certified in year 2000.
GMP Europe and US FDA standards
Certfications for Galenix Pharma :
Authorization for cGMP manufacturing, importation and distribution of human medicinal products
and investigational medicinal products AFSSAPS # M09/168.
Authorization for cGMP manufacturing, importation and distribution of veterinary medicinal products
and investigational medicinal products AFSSA # V1515/08.
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