Research & Development is experienced in the development of new products, from the selection of the most suitable raw materials, up to the definition of process parameters based on the most recent technologies and trends.
Thanks to our consolidated know how in the ophthalmic field, complex problems can be rapidly solved by our team, investigating a broad range of process parameters.
Our mission is the delivery of a solid formulation through the pre-formulation studies according to the Quality by Design approach.
• Preparation of Technical Files for Medical Devices
• Preparation of Medical Devices clinical evaluation
• Registration of Medical Devices in the Italian MOH database
• Assistance for the e-CTD dossiers development
• Manufacturing Authorization, first issued in June 1997
• GMP Compliance of a Manufacturer
• UNI EN ISO 9001:2015
• UNI EN ISO 13485:2016