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eCTD Publishing
What is eCTD ?
eCTD-Electronic Common Technical Document is a system based on a set of specification used by the pharmaceutical industry to send regulatory documents to regulatory bodies.The eCTD Specification are published by regional FDA bodies and ICH.eCTD is based on 5 Module CTD strutcute.An eCTD Submssion has an XML backbone that provided vital information to the reviewer on the submission and its lifecycle.Perfect Pharmaceutical Consultants provides following eCTD services
- Compilation of USDMF in eCTD
- Paper to eCTD Conversion services
- eCTD Publishing
- eCTD Submission service to USFDA, Health Canada, EDQM, EMEA
- Filling of US Drug Master Files(DMF Submission),Certificate of Suitability(CEP),TYPE II DMF ,Master Files,CTD Dossiers
- Originals, Amendments, Annual report Submissions,eCTD baseline Submissions,Medical Device Submissions
- eCTD Life Cycle Maintenance
Food and Drug Administration (FDA) USA
Drug Master File Submission
As of 5th May 2018, US FDA requires all applications for DRUG Master File ( US DMF) TYPE II, IV, and V to be in eCTD Format,all submission in NON eCTD Format after this date will be rejected by US FDA.Which Type of Submission are required in eCTD Format ??
- Original Application - NEW DMFs
- Annual Reports
- Amendments
- Issue of Letter of Authorization, Withdrawal of Authorization
Perfect Pharmaceutical Consultants Pvt LTD is a specalist in eCTD Conversion and Filling
WE have a strong regulatory and IT team to help you comply with this requirement at low cost.
Contact US NOW to disucuss your eCTD DMF Submission and Publishing requirement.
Resources for eCTD
Article - How to comply with USFDA eCTD Requirements ?
Article - Buying an eCTD Software vs Outsourcing eCTD Submissions and Publishing ?
