This consultancy service supports research institutions, academia, SMEs, spin-offs and startups developing medicinal products, medical devices, IVDs and combination products. It helps navigate the manufacturing (CMC- Chemical, Manufacturing & Controls), regulatory and clinical landscapes from early development to registration in EU, US, UK, Switzerland and Health Canada.
Key components include:
a) Regulatory classification of the product (e.g., drug vs. device/IVD);
b) Regulatory roadmap outlining development steps, documentation, and timelines up to clinical trials or CE marking;
c) Support with regulatory authority engagement (e.g., FDA/EMA/EU Health Authorities interactions, device consultations, innovation offices);
d) Expert reports on regulatory strategies, requirements, and development plans;
e) Guidance on procedures, such as Orphan Drug Designation or SME status;
f) Training and coaching, through workshops or individual sessions.
The service includes strategic advice to ensure regulatory alignment, optimise planning, and reduce risks. It is available at any development stage, with scope and timeline adjusted to project complexity. Deliverables include tailored roadmaps, strategic recommendations, and if applicable, summaries of agency interactions to support regulatory compliance and market entry.
High level assessment is provided free of charge for EIC beneficiaries. Thereafter, the budget will depend of the scope of work but a typical assignment such as a regulatory strategy (crafting tailored regulatory pathways for product development and approval) may start at €10,000 - €20,000. This will vary depending on the scope of the assignment (regulatory agency interactions, dossier preparation and submission, QMS implementation, etc.).
Intellectual Property & Legal
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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.