A company can request Scientific Advice (SA) from the European Medicines Agency (EMA) or the National Competent Authorities (NCAs) at any stage of development.
SA helps to ensure the identification of appropriate studies in line with regulatory requirements so the advice may contribute to avoiding major objections during the evaluation of the Marketing Authorization Application (MAA).
Agencies provide SA by answering questions, which are usually related to quality, non-clinical, clinical and regulatory aspects of development.
DDR and its network have experience in a large number of therapeutic areas and an in-depth knowledge of key regulatory issues to support the SA.
How can DDR help?
- DDR and its network support scientific discussions in a large number of therapeutic areas and key regulatory issues.
- DDR will prepare the logistics and all documentation required for the SA meetings and follow-up procedures.
- DDR will give recommendations regarding which regulatory Agency is the most appropriate for a particular case, and the most suitable time for requesting the SA.
- DDR will attend and manage the meetings as the regulatory representative of the sponsors, if required.