Regulatory Authorities (RA) according to ICH guideline includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as Regulatory Authorities (RA).
Following local laws for countries’ within Biomapas coverage list, we will prepare initial submission packages (including all documents required).
We complete EudraCT application (for EU countries) and prepare all other country specific templates, including collecting all essential documents from the sites and documents received from the Sponsor.
While preparing the pack, team also assures arranging prepayments where needed and perform submission. After submission completion, all validation queries are handled according to provided timelines.