Understanding the differences in legislation, national guidelines and medical practice across different regions and/or countries is essential when planning your regulatory strategy. The way a particular medical condition is managed and the standard therapy used can differ and in turn affect the approach you take. A key challenge is successfully navigating the regulatory landscape. This information can sometimes be difficult to obtain without access to specialists based within the appropriate area. Sometimes a significant amount of research is needed to determine which comparator or endpoints in a clinical trial will satisfy the requirements of the local regulatory authority. This is particularly true for innovative therapies or for orphan indications.
How can we help?
Our team of consultants have a proven track record of successful regulatory approvals. Coupled with their vast breadth and depth of experience, this enables them to be able to provide you with coherent strategic input when undertaking the necessary research required to devise a development plan for your individual product or therapeutic programme. They can support you by advising on the appropriate regulatory strategy, recommending the best route to the market, drawing up formal project plans with resource allocation, guiding you through study design and protocol preparation, and continually monitoring the project to ensure it stays on track.
You will be able to find further valuable information relevant to your particular circumstances by following these links: Pre-authorisation, Post-authorisation, Scientific Consultancy, Regulatory Support for Clinical Trials
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION