Kinesys Principal staff have extensive experience in the preparation and approval of over 100 global Marketing authorisations. Dossiers have been prepared and submitted globally to EMA and national agencies such as FDA, Health Canada, and TGA.
Based on this wide knowledge we will guide and assist you through the preparation of the authorisation process from the pre-application activities and Agency interactions to the actual submission preparation and navigating the approval procedure itself.
We have authored and reviewed all of the different Modules of the CTD package for MAA for many products. Our writing service is especially used for the Module 2 components.
Responding to Agency questions is crucial, as is liaison with the assessors. Between us we each 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, help prepare and advise on the Oral Explanation and any potential 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 Advisory Board members are often useful in this case.