This service supports startups in navigating regulatory compliance requirements for the commercialisation of Life Sciences products. Designed for early-stage companies preparing for market entry in the EU, the service is delivered over a period of 3 to 4 weeks by in-house regulatory experts.
The service includes three key phases:
1. Regulatory Landscape Assessment: Experts identify the applicable regulatory pathways based on product type, risk class, and intended use.
2. Roadmap Development: A tailored regulatory roadmap is developed outlining essential steps, timelines, and documentation needs to achieve compliance. This includes recommendations on technical file content, performance evaluation, labeling, and quality standards.
3. Review & Advisory Sessions: The roadmap is discussed with the EIC beneficiary in dedicated consultations to validate feasibility and readiness. Strategic advice is provided on how to manage regulatory risks and accelerate certification. The expected outcome is a clear, actionable regulatory roadmap aligned with the EIC beneficiary’s go-to-market strategy. The service is delivered online via expert consultations and review sessions, with follow-up support available upon request.
€500 - €3500.
The expected timeframe for service completion is approximately 3 to 4 weeks.
Intellectual Property & Legal
Are you in doubt if this is the right service for you, or do you want to get more information about the service? Get in touch with the EIC Partner providing this service through this query form!
Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.