C.F./P.I. 00208120287 - Direzione e coordinamento H. Lundbeck.A/S
The QA and Regulatory Affairs Department has been committed for many years to comply with all relevant GMP requirements from Health Authorities Worldwide. The commitment to GMPs has resulted in regular and excellent inspection records with the Italian AIFA, the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the Korean FDA.
The regulatory specialists at LUPI are able to produce, in close collaboration with the customer, high quality technical dossiers (DMFs, CEPs) to support a smooth and fast registration of the Drug Product with Health Authorities Worldwide. A qualified customer service on the technical and regulatory issues is also guaranteed, post approval, to cover customers’ needs in a timely and accurate manner.