Production sites
-
Audit and cooperation for dossier preparation in order to obtain a GMP certification or other certifications required by extra EU countries for medicinal products and raw materials manufacturing sites
-
Regulatory compliance for engineering, creation and revamping of manufacturing plants
-
Support for manufacturing plants, lines and process validation procedures
-
Achievement of GMP authorizations or change in pre-existing authorizations
-
Achievement of the required authorizations for production of drugs, veterinary products, medical devices and nutritional supplements
-
Technical and regulatory assistance to biocide, medical device and cosmetics manufacturing plants
-
Relationships with the Italian medicines agency (AIFA) concerning the requirements related to the identification activity for GMP qualification
-
Follow-up activities after government inspections and dossiers and documents preparations to face any possible observed deviation
-
Preparation and management of the substantial or non-substantial variations for production sites
+390686391873
info@consulfarm.it
Viale Somalia, 164