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As Horizon 2020 came to an end, Obelis is excited to announce that it will now be a potential regulatory partner for a new prominent EU key funding programme for research and innovation, Horizon Europe.
Horizon Europe has a budget of 95.5 billion euros and will operate from 2021 to 2027. This exciting initiative for researchers and innovators sets out to create future-oriented innovation with a major social and environmental impact.
Our commitment and role in Horizon Europe
Obelis shows the same ambition as Horizon Europe to boost EU competitiveness and growth:
- Up to 11 of GDP gains over 25 years to be generated by each euro invested in R&I
- Over 35% of Horizon Europe budget to climate objectives
- To create 300.000 jobs by 2040, of which 40% will be highly skilled jobs
Together with all partners, Obelis will ensure regulatory compliance of the project and its results towards relevant target groups. In addition, Obelis will support all partners in their activities and questions concerning EU Regulations and compliance throughout the project.
Our goal is to use our regulatory experience to help our community by providing compliant projects and overcoming regulatory issues. Our special focus is on medical devices, pharmaceutical and health technologies, artificial intelligence, smart cities, cybersecurity, GDPR, personal protective equipment.
Our role in Horizon Europe
- Expert in the security field involving ethical and societal aspects
- Review and compile all documentation needed to assure a compliant prototype product
- Identify regulatory requirements, standards, and specifications
- Assist all partners to properly explain, document, justify and validate all analytical tools, experimental steps and methods used
- Contribute to the knowledge of all partners by maintaining an ongoing and close reference to current and future legislation and regulation
- As an EU leader in healthcare device regulation, Obelis offers related project services as well as consultancy, and guidance on technical file creation and review, and more
Our pharmaceutical regulatory experience
The Obelis pharma regulatory experience focuses on developing efficient processes to ensure regulatory compliance and monitoring their implementation, particularly in:
- Data review, compilation, submission, and follow-up of Marketing Authorizations Applications
- Maintaining regulatory compliance throughout the product lifecycle
Obelis has been a key partner as a regulatory advisor for various EU Horizon 2020 projects; of particular relevance, in this case, is HypoSens, for the development of a nanomedicine and diagnostic device combination product.
Obelis’ role was to provide regulatory intelligence and advice for compliance throughout the project, including oversight to ensure that design and development phases and processes were suitably structured and robust to meet regulatory requirements, and that necessary documentation was generated in a timely manner.
If you are a Researcher or an innovator, you are invited to present your projects that address global issues such as healthcare and climate change and Obelis will be happy to be your regulatory partner.