Horizon Europe Collaboration - HTA and regulatory affairs - Betthera s.r.o.

We are Betthera s.r.o., a Czech consulting company specialising in health technology assessment (HTA), health economics, regulatory affairs, and impact assessments for medical and emerging technologies within European research and innovation projects. Our mission is to deliver high-quality evidence, strategic insights and decision-critical assessments that support the development, implementation, regulatory compliance and successful adoption of innovative healthcare solutions.

Who We Are
At Betthera, we help organisations — including SMEs, research institutions, and industry partners — to evaluate the effectiveness, economic value, social impact and regulatory readiness of new health technologies.

Our expert services include:
• Health Technology Assessment (HTA) aligned with EU frameworks
• Economic evaluations (cost-effectiveness, budget impact, decision-analytic models)
• Systematic literature reviews and meta-analyses
• Regulatory strategy and compliance support for medical devices (CE marking, technical documentation, QMS)
• Business modelling and market access planning

Our Focus in Horizon Europe Projects
We bring strong expertise to research consortia by:
• Leading or contributing to HTA and health economics work packages
• Translating clinical, real-world and behavioural data into evidence that supports policy and reimbursement decisions
• Shaping regulatory strategies to ensure compliance under EU MDR and other frameworks
• Supporting project design with clear impact assessments and sustainability perspectives

We have successfully participated in multiple EU research collaborations, bridging evidence generation, regulatory insight, and strategic planning to help consortia deliver meaningful outputs and societal impact.

We are seeking for suitable consortium to join with our expertise.