eCTD/CTD (Common technical document)

Home / eCTD/CTD (Common technical document)

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. The Common Technical Document is divided into five modules:

  • Administrative and prescribing information
  • Overview and summary of modules 3 to 5
  • Quality (pharmaceutical documentation)
  • Preclinical (Pharmacology/Toxicology)
  • Clinical – efficacy and safety (Clinical Trials)
Our Valued Sponsors:

Site Office

Indivirtus Healthcare Services, 1st Floor, D-258, Industrial Area 8A SAS Nagar, Mohali Punjab 160055, India

Registered Office
5020 A, Sector 38 West Chandigarh 160014, India

Contact

marketing@indivirtus.com
+91 172 4028586,
+91 9131925456,
+91 6280918142

Open hours

Monday-Saturday: 9:30am-6:30pm
Sunday: Closed