Australian Therapeutic Goods Administration
Agencija za lijekove i medicinska sredstva Bosne i Hercegovine
Health Canada Santé Canada
Swiss Agency for Therapeutic Products
China NMPA CDA
Centralised, National, DCP, MRP
Saudi Food & Drug Authority
Jordan Food and Drug Administration
Singapore HSA
Thai Food and Drug Administration
National Agency for Medicines and Health Products
Ukraine SEC-MOH
U.S. Food and Drug Administration
World Health Organization PQT
South African Health Products Regulatory Authority
Therapeutic Goods Administration
Non-eCTD EU Electronic Submissions
Agencija za lekove i medicinska sredstva Srbije
Swissmedic VNeeS: pharmaceutical, biological, immunological
EU VNeeS: pharmaceutical, biological, immunological or MRL
GCC VNeeS: pharmaceutical, biological, immunological or MRL
Prior to filing your eCTD (Electronic Common Technical Document) submissions to regulatory agencies you should make certain your sequences are technically valid.
(Re)viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD (3.2.2 and 4.0), NeeS, VNeeS, eDok and other electronic dossier formats.
Create, view, edit, annotate (create links), OCR and digitally sign PDF files. Convert, merge documents, extract pages, optimize, generate bookmarks, add headings, ...
PDF documents and hyperlinks: explore, adjust, delete, fix broken, optimize, ...
Compare two eCTD sequences visually instantly. Missing files, orphan/empty folders, differences in MD5, ...
Quick conversion of an electronic submission to paper.
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