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Dossiers - Common Technical Documents (CTD)

Common Technical Documents (CTD) is set of specification describing a specific format for registration dossiers which will be accepted in United States, Europe and Japan. The format for CTD is same across all the 3 nation but the content changes for every country.(Module 1)

Common Technical Documents are used to obtain Market Authorization across different nations. CTD formats is now being adopted by many nations.

eCTD is an electronic format which will replace the paper designed CTD eventually.

Common technical Documents is divided in 5 models

  1. Administrative and prescribing information
  2. Overview and summary of modules 3 to 5
  3. Quality (pharmaceutical documentation)
  4. Safety (toxicology studies)
  5. Efficacy (clinical studies)

We add value by:

  1. Preparation of dossiers in CTD format for Market Authorization (MA) in various countries.
  2. Consulting and preparation of all five modules for registration purpose in any country.
  3. Re-formatting old Dossier/DMF to CTD format.

CTD Resources

CTD Dossier Index (Sample)

List of Products prepared in CTD format

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