Why do manufacturers require regulatory support for the Horizon Europe Program?
Background
Proper regulatory support helps teams focus on innovation while navigating complex compliance landscapes, critical for achieving Horizon Europe’s ambitious goals.
Successful participation in Horizon Europe requires strict regulatory compliance to:
- Meet EU project requirements and milestones
- Secure smooth approval for medical, health, and pharmaceutical technologies
- Ensure data validity, ethical standards, and documentation integrity
- Reduce risks of project delays or funding issues
Our services
Partner with Obelis for Regulatory Success in Horizon Europe
Obelis provides:
- Regulatory Intelligence & Guidance on EU legislation and compliance pathways.
- Documentation Review & Compilation for project submissions and technical files.
- Support with Marketing Authorisation Applications and lifecycle compliance.
- Advice on Clinical Evaluation and Regulatory Strategy for medical and health technologies.
- Ongoing Monitoring to maintain alignment with evolving EU standards.
With decades of regulatory expertise and experience with Horizon Europe projects, Obelis ensures your project is compliant, efficient, and funding-ready. Partner with us to ensure the regulatory success of your Horizon Europe project.
FAQ
Frequently Asked Questions
Horizon Europe Compliance Support refers to the regulatory guidance and consulting services provided to ensure that your research and innovation activities meet all legal and safety requirements under the Horizon Europe framework. This includes support with ethical standards, regulatory pathways (e.g. for medical devices or substances), technical documentation, and conformity procedures required for EU-funded projects.
Regulatory compliance is critical to the success of Horizon Europe projects. It ensures that your innovation can legally and safely reach the European market. Non-compliance may lead to funding delays, project disruptions, or the inability to commercialize your results. Early regulatory planning reduces risks and enhances the credibility and impact of your proposal.
Any consortium, SME, academic institution, or individual researcher involved in a Horizon Europe project that includes product development—particularly in the fields of health, medical devices, AI in healthcare, or chemical substances—can benefit from compliance support. This is especially relevant when a product or process must undergo CE marking or adhere to EU safety regulations.
Obelis Group acts as your strategic compliance partner, offering tailored regulatory intelligence, gap assessments, and hands-on guidance throughout the project lifecycle. We help identify applicable regulations, ensure technical documentation aligns with EU standards, and assist in navigating CE marking processes. Our expertise ensures your innovation is not only groundbreaking—but also legally ready for market.
