Regulatory and Peri-registration Activities

Challenge

A biotech company sought to register an antibiotic for an indication that was not considered acceptable by EU regulatory guidance, using a single small clinical trial in a condition of high medical need.

Solution

tranScrip undertook the preparation of clinical sections of the MAA based on the reanalysis of the data package previously submitted to FDA, maintained a close dialogue with agency assessors and key opinion leaders to champion the need in this indication and followed the registration process throughout including support for oral hearing.

Result

The desired label indication was achieved.