eCTD - Publishing

RegInfo could help you in the following categories:

Creating eCTD baseline for BREXIT and other national procedures
Using a validated eCTD publishing tool to compile and publish the eCTD submissions
Formatting of Microsoft^® Word and Adobe^® PDF documents to comply with the ICH’s PDF specifications
Creating hyperlinks between the various CTD sections for ease of navigation and review
Compile NeeS
Conversion from ACTD (for ASEAN countries) to eCTD
Consultancy in dossier compilation for: EU, USA

We have extensive experience in publishing the following regulatory documents to the:

EMA
- Centralised procedures - Initial Marketing Authorisation Application (MAA)
- Variations
- PSUR submissions
- Submissions via eSubmission Gateway
EDQM
- ASMF
- ASMF for CEP
European Health Authorities
- MRP & DCP dossiers and other submissions
- National dossiers and other submissions
- Submissions via CESP
FDA
- Original Dossiers:
  - New Drug Application (NDA) Investigational New Drug Application (IND)
  - Biologics License Application (BLA)
- Supporting Documentation:
  - Protocol amendments
  - Investigator documents
  - Promo materials
  - Expedited pathway submissions
  - Annual Reports
- DMFs