Our services Medical Writing Regulatory affairs |
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Regulatory affairs
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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