CRED Practical Document Writing and Management

RMS Day 70 Preliminary Assessment report

12 Major objections on quality 123 points for clarification on quality

2 major objections on the pre-clinical 7 points for clarification on the pre-clinical

5 major objections on the clinical (including the indication) 26 points for clarification on the clinical (including he risk management plan)

1 major objection on Module 1 3 points for clarification on Module 1