eCTD Publishing-

– eCTD Compilation, QC Review, Technical Validation and Submission Hosting
– eCTD Lifecycle Management
– Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
– Importing and Cloning of Existing eCTD Applications
– US FDA: ANDA Dossiers 505j, 505(b)(2), CBE0, CBE30, PAS, API DMF Type-II, Type-IV-Excipient DMF,
Type -III Packaging, Amendments, Annual updates, query responses etc…
– EU: MAA Dossiers for National/DCP/MRP, ASMF, CEP, Query responses, Renewals, variations etc…
– GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc…
– Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW: Dossiers, DMF, Query responses,
Renewals, variations etc…
– Pdf publishing: PDF – Ready for Submission, Bookmarking, Hyperlinking,
– OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements

DMF Submissions:

CTD DMF writing, filing and eCTD Publishing for :
US-Type –II DMF – API, Type-III – Packaging material, Type-IV – Excipient
EU- ASMF and CEP (Applicants Part & Restricted Part), Open & Close part,
WHO DMF, China-DMF, Japanese DMF, CTD DMF for all countries.
eCTD conversions: DMF original, filings annual updates, changes etc
DMF and CEP submission via electronic portals to EU, USA and WHO
Excipient DMF Writing and consultation
Packaging material DMF writing and consultation