eCTD Dossier Preparation

eCTDs are used to obtain Market Authorisation accross different nations. There are five modules for an eCTD:

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

For details, visit KnowledgeNET...

eCTD dossier preparation is one of the solutions that Sarjen provides under KnowledgeNET. Submissions using our KnowledgeNET solution for eCTD dossier preparation are well accepted by various regulatory agencies. Sarjen's eCTD submission follows ICH guidelines and is 21 CFR 11 compliant.

We can prepare dossiers in eCTD format for Market Authorisation. Also, provide consulting and preparation of all the five modules for registration purpose in USA and Europe. We also re-format old dossier/DMF to eCTD format.

Sarjen's eCTD submission management solution helps to create, store, organise, share and publish eCTD submission for various regulatory agencies quickly, efficiently, reliably and securely.

It has an in-built document management system which provides scalability and flexibility to adjust to needed regulatory needs, while specific features like Study Tagging Files (STF) and Regional Envelops add user friendliness to create XMLs for complex submissions.

The solution can deal with submissions having multiple APIs and multiple manufacturers for each API. Our solution can cater to National, Centralised, DCP (De-centralised Procedures) and MRP (Mutual recognition procedures) requirements.

Some of the features of our eCTD dossier preparation solution includes:

• Life cycle management using embedded Document Management System
• Pre loaded Document templates available with necessary usage guidelines
• Study Tagging Files (STF) for US FDA
• Regional envelops and tracking sheets for EU DCP and MRP
• Provides facility to create and validate hyper linking within the structure

For details, visit KnowledgeNET...