Regulatory EMA and registration support
Aepodia provides solid regulatory support to assist you with EMA and FDA comments and suggestions.
We efficiently manage national marketing authorisation applications, and control their quality.
You can trust us to:
- understand and manage submission requirements for non-eCTD electronic submission (NeeS);
- define or review a submission’s structure prior to writing;
- assess your NeeS applications for compliance prior to submission;
- prepare NeeS submissions from core document writing to filing; and
- answer ad hoc questions.
We can also help you write and review scientific advice documents (EMA) and FDA briefing documents.