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 AUSTRIAÂ
Occupational Health and Safety Management Certification (ISO 45001:2018) – TÜV AUSTRIA
Business Continuity Management Systems (ISO 22301:2019) – AQS CERT