Medical devices

Manufacturing of medical devices for third parties and in out-licensing

The competence and ability to analyze market trends, combined with continuous collaboration with research centres of excellence, allow Biofarma Group to develop and manufacture innovative and effective ready-to-market medical devices, both for third parties and in out-licensing.

The medical devices, regulated in a separate matter compared to pure nutritional supplements, are products that act on the body in a chemical-physical and/or mechanical way. For this reason, medical devices represent highly effective remedies and allow the brand owner to advertise the product by highlighting its therapeutic and preventive effects.

From the design of medical devices to labelling

Biofarma Group manages the entire production phase of medical devices: from design to collection of technical, clinical and toxicological data up to labelling, following the procedures required by the Certifying Body and in full compliance with the standards set by current regulations. The full-service management of a project implies the active participation of a team of collaborators.

We deal with class I, IIa, IIb and III medical devices in solid and liquid format. The products, for topical and oral use, are aimed at different therapeutic areas and are meant to tackle gastrointestinal, oral and oropharyngeal, dermatological, proctological and vaginal disorders.

The production of out-licensing medical devices

We manufacture more than 70 ready-to-market products, many of which are patented. Biofarma Group’s production of out-licensing ready to market medical devices includes over 70 products, some of which are patented. We take care of every phase of the process: from the formulation to the development of the product up to the coordination of every certification-related activity. Our activity includes the biocompatibility and stability tests and the drafting of the technical file. Our goal is to increasingly expand the number of countries in which to register and market medical devices created within the Group’s R&D laboratories by starting targeted partnerships with pharmaceutical companies located throughout the territory. Therefore, the out-licensing activity focuses mainly on the search for new licensees or distributors in the areas where the group, to date, is not directly present.

The production of medical devices for third parties

At Biofarma Group we accompany our customers through the whole process, analyzing needs and meeting requests to make their presence on the market unique. 

We propose and implement innovative solutions in all therapeutic areas: from the gastrointestinal and metabolic area to personal hygiene, from childcare to skin protection, from coughs and colds to allergies, up to intimate hygiene and the proctological area.

The service includes consultancy for the preparation of the Technical File and the supporting scientific rationale, the search for supporting scientific studies, notification of the Medical Device and assistance in obtaining the authorization of the Ministry of Health for health advertising.