Innovative Regulatory Affairs Strategies for Innovative Products
EU/UK Legal Representative Services
- IDEA is passionate about getting innovative products to patients with unmet needs and we particularly enjoy putting our full weight of innovative thinking and regulatory expertise behind innovative medicine.
Helping you to help
- Our goal is to attain the best possible results for patients, by understanding the goals of our clients, cooperating with authorities, and utilising available regulatory incentives to accelerate assessment, while delivering quality data for regulatory approval.
Working as part of
- We work as part of your team and are fully with you on your regulatory journey , helping to navigate the complex and ever-evolving global regulatory and market access environments, pre-empting and managing the common misunderstandings that can cause you unexpected costs and delays.
Pharmaceutical industry knowledge
The In Vitro Device Regulation (IVDR) comes into force on 25 May 2022, which means companies must start complying with the regulations. While we’re seeing many companies have aspects in place, there are many issues that they may not have considered. For example, if you’re using a biomarker assay in your clinical study, has it […]
Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational. Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to […]
Good clinical practice is well-entrenched in global biopharmaceutical companies, and almost every sponsor company adheres to the Declaration of Helsinki with regards to following ethical principles in their medical research. For US companies, the standards established by the Food and Drug Administration (FDA) are very much in line with what is required in the European […]