Certifications (&Compliance)

We are committed to the highest quality and safety standards in pharmaceutical manufacturing. Our facilities and processes comply with stringent national and international regulations, ensuring the efficacy and safety of our products.

CERTIFICATIONS FOR HUMAN USE DRUG PRODUCT

FDA – Food and Drug Administration

GMP – National Agency for Medicines and Medical Devices of Romania

CERTIFICATIONS FOR VETERINARY PRODUCTS

GMP – United States Department of Agriculture (USA)

GMP – National Authority for Sanitary Veterinary and Food Safety (Romania)

GMP – The Federal Service for Veterinary and Phytosanitary Surveillance (Russia)

GMP – Ministry of food, Agriculture and Livestock (Türkiye)

ISO STANDARDS

Quality Management System (EN ISO 9001:2015) – TÜV AUSTRIA

Medical Devices – Quality Management System Certificate (UNI CEI EN ISO 13485:2016) – KIWA CERMET ITALIA S.p.A

Medical Devices – EC Quality Assurance System Certificate (CE mark) – KIWA CERMET ITALIA S.p.A

Environmental Management System Certification (DIN EN ISO 14001:2015) – TÜV AUSTRIA 

Occupational Health and Safety Management Certification (ISO 45001:2018) – TÜV AUSTRIA

Business Continuity Management Systems (ISO 22301:2019) – AQS CERT