Development is the earliest stage of a medicinal product lifecycle. A meticulous scientific approach is applied to gain a comprehensive understanding of the product and manufacturing process in order to prove that the type of dosage form selected and the formulation proposed are suitable for the intended use. In this phase the safety and efficacy of a product are established through a series of pre-clinical and clinical studies, whose results are fundamental for the submission of the marketing authorization application to the competent Health Authorities.

Marketing Authorizations are mandatory for the production and commercialization of medicinal products, whose application process is strictly regulated and it may differ according the geographic areas of submission.

Information on quality, safety and efficacy are requested and critically reviewed by the Health Authorities that may ask for clarification or additional data. Therefore the whole process requires some time before the Authorities reach a conclusion.

Only after the approval, the company makes a medicinal product available to patients.

Production and control are performed within the Production Sites which have been authorized by the National and Local Authorities, following the positive results of the periodic inspections which have the objective to evaluate the Sites compliance to the Good Manufacturing Practices.

Being Menarini an International Company, its Production Sites are inspected by Health Authorities from all over the World.

All the activities performed within the Sites are ruled by operative procedures with the Quality Assurance Department supervision.

Medicinal products have to be stored and transported according to the climatic conditions described in the Marketing Authorization in order to avoid any negative impact on their quality. Menarini has procedures in place to continuously monitor Temperature during the storage and the transport and to select suitable carriers, whose trucks are equipped with air conditioning system able to guarantee that the correct Temperature is maintained throughout the travel.

Maintenance involves the commercial phase of a product lifecycle, strengthening quality and resulting in a benefit for patients.

It deals with a periodical quality review of the products, gathering all the necessary information to highlight trends and points which may require more attention or improvements. It deals also with the implementation of changes to a product by promoting innovation, through new technologies application.