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)