Six tips for delivering top-class dossiers.
Practical pointers to navigating authority guidance and
getting the balance of technical eCTD content right first time.
From the conception of a pharmaceutical product, data is captured about its chemistry, about its manufacturing and about any relevant controls.
When it comes to applying for marketing authorization, much of this information will form the basis for the CMC sections of the eCTD dossier (Module 3: how a product was made and tested) for submission to various licensing authorities.