The Regulatory Development Roadmap aims to define the regulatory pathway in Europe of a medicinal product, medical device and/or in vitro diagnostics, providing the key features in terms of quality, nonclinical, clinical and regulatory requirements of the development of the product. Within the Regulatory Development Roadmap, EIC beneficiaries will have a clear understanding of the development steps that should be taken to get an end goal, such as starting a clinical study, authorisation or certification of the product in Europe, among others. EIC beneficiaries will receive a regulatory report that details the regulatory pathway of the product in Europe. The Report will be provided in pdf and will include the categorisation and classification of the product according to applicable regulations and laws, the quality, nonclinical and clinical requirements that need to be conducted before the end goal and the regulatory requirements through all the development pathway. The Roadmap will be conducted according to a specific end goal that will be discussed with EIC beneficiaries before the start of the project. Additionally, before the start of the project, a kick-off meeting with regulatory experts will be conducted. Upon the delivery of the regulatory report, a discussion meeting will be held with regulatory experts to discuss any doubts or questions.
The Regulatory Development Roadmap will be offered at a price of €12, 000-€18,000 depending on the indication and product characteristics.
BCCC will provide the Regulatory Development Roadmap to EIC beneficiaries and Seal of Excellence holders at a reduced price. The Regulatory Development Roadmap is considered a key strategic document essential for most companies in the healthcare sector, since will guide the development of the product since early to more advanced stages. Service timelines will be discussed specifically for each project.
Intellectual Property & Legal
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