DMF Submissions:

DMF Gap Analysis
DMF preparation from writing to publishing to submission to global health authority.
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

Online Electronic Submission Gateways :
– Europe – CESP
– USA FDA – ESG
– Additions in progress.

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