CTD
Common Technical Document (Product Dossier) is an Integral Part of any registration application for Marketing Authorization. Dossier in CTD Format is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions.
Seedling RA Solutions can help you prepare an entire technical document for drug product registration in various countries all over the world.
PREPARE, REVIEW AND SUBMIT
Format: CTD Guideline (ICH/RoW)
Module 1 – Administrative Information and Prescribing Information
Module 2 – CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 – Quality (S part – DMF & P Part – Finished Product)
Module 4 – Nonclinical Study Reports (Literature-Based)
Module 5 – Clinical Study Reports (Literature-Based)