Lyonbiopôle supports its members to prepare them as well as possible for regulatory procedures and access to markets
Developing a relevant regulatory strategy, anticipating any changes, targeting and prioritising the main strategic markets are all challenges that face companies in the health sector. Through various tools and devices, Lyonbiopole offers first level support to its members to best prepare for these processes. Our support includes:
For any company, protecting its innovation is an essential prerequisite and a priority in its development plan. Workshops are organised every year on this theme together with specialised firms.
Lyonbiopole works to inform companies on the specificities associated with the main strategic markets they target.
The aim is to provide them with first-level information to address regulatory issues, access market data, identify distributors, influencers or regulators, and obtain the basics about how the countries in question function on a cultural level.
In order to support MedTech actors in their medical CE marking procedures, Lyonbiopole and the Auvergne-Rhône-Alpes Region set up a CE marking support system in 2019.
Lasting one year, it includes services aimed at compiling the CE marking application through a subsidy (capped at €20,000 excluding VAT) of up to 50% of the eligible expenses. To do so, the Region and Lyonbiopole are supported by the skills of the Agence Auvergne-Rhône-Alpes Entreprises and the SNITEM.
The Auvergne-Rhône-Alpes Region’s support scheme for obtaining authorisation to begin clinical/biotech trials aims to provide financial support to biotech SMEs in the preparation and planning of their pre-clinical and clinical development stages.
The aim of this programme is to accelerate the R&D phases by using better sequencing and planning of the development phases and facilitating the development of preclinical development plans from the discovery phase to the Investigational New Drug Application (IND): the various preclinical stages, Good Manufacturing Practices (GMP) compliant production, formulation, preparation of the clinical phase, etc.