The quality promise of Biofarm® means to create, manufacture and market products that meet the purpose for which they were designed, following marketing authorizations and marketing notifications, which does not expose patients to any risk caused by deficiencies regarding their safety, quality and effectiveness.

Our company expresses the implied agreement of all its members to achieve performance on all levels, including those in the field of occupational and environmental health and safety.

Biofarm® has the following certifications:

ISO 9001:2015 - Certificate no. 20100233018436 for Quality Management system that complies with the requirements of the EN ISO 9001:2015 standard

ISO 14001:2015 - Certificate no. 20104233018437 for Quality Management system that complies with the requirements of the EN ISO 14001:2015 standard

Manufacturing authorization no. 9F issued by ANMDM

Notice of operation of medical devices no. 6254 of 18.11.2021

Certificate for compliance with requirements of ISO 13485-2016

Integrated Policy of Quality, Environment, Health, and Safety at Work 20.10.2023

Certificate of Good Manufacturing Practice no. 048/2023/RO issued by ANMDM

Certificate of Good Manufacturing Practice no. 049/2023/RO issued by ANMDM

Certificate of Good Manufacturing Practice no. 050/2023/RO issued by ANMDM

Certificate of Good Manufacturing Practice no. 051/2023/RO issued by ANMDM

ISO 45001:2018 - Certificate no. 20116233018438 for Quality Management system that complies with the requirements of the EN ISO 45001:2018 standard

SR EN ISO 13485:2016 - Certificate no. 187 for Quality Management system that complies with the requirements of the SR EN ISO 13485:2016