Regulatory affairs

Submission of the essential clinical documents to Ethics Committees and Competent Authorities
Exhaustive literature review
Preparation of CTDs
Quality, nonclinical and clinical summaries and tabulated summaries (CTD Modules 2.3, 2.6 and 2.7)
Nonclinical Overviews (CTD Module 2.4)
Clinical Overviews (CTD Module 2.5)
Summary of Product Characteristics (SPC)
Patient information leaflet (PIL)
Test of readability and usefulness of patient information leaflet (PIL)