Consolidated know how and experience in the research, developpment and production of monoclonal antibodies, proteins, cells for cell and gene therapy, tissue engineering, diagnostic kits, cell-based and biochemical assays, set up and validation of analytical methods
-The management of GMP production and of Quality Control through a Quality System, experienced in a considerable number of inspections of major international regulatory bodies. This allows the management of any kind of request for authorization to clinical development.
-Very deep know how and experience of technologies and solutions for the production of sterile galenic forms as, infusion bags, cryovials, vials and ampoules with everything necessary for an up to date sterility assurance.
-Long term experience and know how in the management of intellectual property
-Long term experience in italian, european, USA rules of patents.
Matured experience in moving research projects to the commercialization, selection of the appropriate partners for the deal, managing of deals, due to a good knowledge of Italian, European and USA biotech and pharmaceutical market
-Very deep experience in start up, establishment and management of small medium enterprises
-Long term experience in project management as useful tool for progression of projects along all the ways in the development of a pharmaceutical from research to commercialization.
-Management of resources (economical and human) in any kind of organization (vertical or matrix)
-Setting up and commissioning of new or revamped R&D and production facilities.