At any stage in a drug’s development a Company is able to seek advice from the European Medicines Agency (EMEA) via the Scientific Advice Procedure. The type of advice requested could be as diverse as seeking clarity on the need for a particular non clinical study to seeking advice on a comparability programme that is being planned for assessing bioequivalence of a product following commercial scale up.
It is also possible to request meetings with national agencies, for example, to provide advice on the design of a clinical study or simply to present the results of a completed phase in the development program.
Shore Limited has direct experience of preparing the documentation required to support meeting requests and in preparing the presentations that are needed for these meetings.
We can also offer advice on the appropriate stage during a product’s development at which to seek advice and the most appropriate route to use.