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
- Original Dossiers: