Regulatory strategy – getting it right at the start, during the process and at the end:
Regulatory / development roadmaps: we analyse your technology and your development and commercial objectives to produce a roadmap that addresses the regulatory challenges and important milestones that need to be achieved and overcome. This is a live document that changes as data become available in development studies. It contains a description of all the important background legislation and guidance as it relates to your product. We bring our knowledge of real products and interactions with regulatory agencies to advise the best route forward for your products. A Regulatory Roadmap is particularly useful for early stage products and companies that have limited in-house regulatory resources, but is also useful at later stages of a product’s development.
Regulatory Applications: EU Scientific Advice and FDA processes and meeting; Orphan Drug designations; Paediatric applications; Clinical Trial Applications; Agency pre-submission meetings (including preparation of Briefing Documents).
Marketing authorisation approval: we will guide and assist you through the authorisation process from the pre-application activities and Agency interaction to the actual submission and navigating the approval procedure itself. Responding to Agency questions is crucial, as is liaison with the assessors. We have many years of experience of successfully working through these challenges. In the event that an EU MAA is initially not successful, we can assist with the appeal (re-examination) process, having successfully overturned initially negative decisions previously for other products. We can also advise on the engagement of independent experts to support your application. Our own Expert Panel members are often useful in this case.
Post-approval activities: We can advise on the Risk Minimisation Plan and, if necessary, any post-approval safety or efficacy studies, as well as registries if appropriate.