Manufacturing sites

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

Viale Somalia, 164