With over 65 years combined experience, we have a long track record of delivering timely solutions for our clients.
We understand the intricacies of the regulatory landscape and the ever-evolving requirements for health technology approvals. We offer a range of services designed to support you at every stage of the preparation and submission process, from initial planning to final submission, and beyond.
- Expertise and Experience: With over 15 years of experience in the healthcare industry, our team of experts brings deep knowledge and expertise in HTAs. We stay abreast of the latest regulations, guidelines, and best practices, ensuring that our clients receive accurate and up-to-date guidance throughout the preparation and submission process.
- Tailored Solutions: We understand that each health technology is unique, and a one-size-fits-all approach does not work. Our services are tailored to your specific needs, whether you’re preparing for a regulatory submission, seeking reimbursement, or demonstrating the value of your technology. We work closely with you to develop a customised strategy that aligns with your goals and maximises the chances of a favourable outcome.
- Comprehensive Services: From initial planning to final submission, we offer a range of comprehensive services to guide you through the entire HTA process. Our services include literature reviews, systematic reviews, economic modeling, dossier preparation, and stakeholder engagement. We ensure that all necessary components of the HTA are meticulously addressed, providing a robust and compelling case for your technology.
- Regulatory Compliance: Navigating the regulatory landscape is a critical aspect of HTAs. Our team is well-versed in the regulatory requirements of different Countries and HTA bodies. We provide guidance on meeting the necessary standards, addressing any regulatory hurdles, and ensuring compliance with HTA guidelines and regulations.
- Strategic Insight: We offer strategic insight and guidance to help you position your technology effectively within the healthcare market. Our experts conduct market assessments, competitor analyses, and value proposition development to ensure that your HTA aligns with market needs and expectations. We assist you in articulating the unique value and benefits of your technology to stakeholders, ultimately increasing its market acceptance and success.
Our services can support Post-Market Surveillance and Reporting once your health technology is on the market. Ongoing post-market surveillance and reporting are crucial. Our team can assist you in establishing post-market surveillance systems, conducting adverse event monitoring, and preparing post-market reports. We ensure compliance with post-market regulatory requirements and help you maintain the safety and efficacy of your product or service.
Odelle Technology have been successful in working with direct decision-makers of the European Health Technology Assessment organisations, capturing the benefits of new technologies, overcoming uncertainties and recognising the value of an innovation, in order to facilitate adoption and / or reimbursement.
To find out more and discuss your project, please contact us.