
Ciencias de la Vida y Salud
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
Many veterinary projects start with the wrong regulatory standard, designed for a sector that was once less regulated. Enforced starts by correcting that premise.
El mercado en detalle
Veterinary medicine manufacturers operate under EMA/CVMP GMP requirements simultaneously with biosafety obligations for live pathogens and viral vectors. These are not separate compliance pathways — they must be resolved in the same physical environment. Production cleanrooms, formulation areas and BSL-1/2 containment laboratories that satisfy both frameworks in a single qualified facility.
Animal facility projects under Directive 2010/63/EU and FELASA guidelines. For US-market manufacturers, USDA APHIS facility standards integrated into the documentation package. For Latin American markets: SENASICA (Mexico), ICA (Colombia), SENASA (Argentina) and SAG (Chile).