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Regulatory affairs

Exhaustive literature exploration

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)

Patient information leaflet (PIL)

Summary of Product Characteristics (SPC)

Test of readability and usefulness of patient information leaflet (PIL)

Contact and advice from key opinion leaders from the preclinical and clinical fields


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