Depending on types of amendments (substantial, non-substantial or notification) we offer full service on submission completion.
For substantial amendment we complete substantial amendment notification form (Annex II) (for EU countries) and including all documents that are impacted. Approval is granted according local law.
Non- substantial amendments are submitted for information.
Biomapas also performs different types of notifications i.e. annual IB updated (if not SA), first patient enrolled notification and etc.