Dossier preparation is a critical step in securing regulatory approvals for pharmaceutical products. The Common Technical Document (CTD), electronic Common Technical Document (eCTD), and Drug Master File (DMF) are key formats used for submitting data to health authorities worldwide.

The CTD streamlines the application process by organizing information into five modules, making it easier for regulators to review. The eCTD takes this a step further by enabling electronic submissions, which reduces paperwork and accelerates approvals.

DMFs, on the other hand, provide confidential details about facilities, processes, or articles used in the manufacturing, processing, and packaging of drugs. These files support the regulatory evaluation of a company’s product without disclosing proprietary information.

Mastering these formats ensures pharma companies submit error-free, well-structured applications, increasing their chances of gaining timely approv