Software with global dossier publishing and life cycle management help the user connect and manage the submission with effectiveness, out eCTD software is very user friendly and ready to use (Out of the Box) software, It connect multiple users parallelly in a user-friendly environment. It is a very light weighted software which does not required very high or complex infrastructure. It has a very advanced engine that allows importing of previous sequence published by any other software and continue next sequence with our eCTD software.
Our eCTD software has Pre-defined templates for :
- US FDA,
- EMA,
- GCC,
- AU-TGA,
- Canada,
- Swiss Medica,
- MCC-ZA,
- Thai-FDA,
- JFDA
Our eCTD software is fully compliant with eCTD module 1 specifications EU v3.0.3, US FDA (v2.01 and v2.3), GCC v1.2 and v1.5, South Africa (ZA-MCC) v2.1, Canada v2.2, Swissmedic (CH) v1.4, Thailand (Thai-FDA) v1.0, AU v3.1, Jordan v1.0.2 and NeeS specifications EU v4.0, GCC v1.2 and v1.5, AU v2.0.
Publish your IND, NDA, ANDA or BLA, DMF(Type1, Type2, Type3 and Type4), ASMF, CEP also the different submission procedure like DCP, MRP, National or centralized submissions
Benefit:-
- Web based software
- No higher IT infrastructure required
- Replication to reduce repetitive work; allows reuse of submissions for other regions
- User and project wise status report
- Use common documents for multiple dossiers
- Auto correction of PDF properties
- In build Technical eCTD validator
- Automatically converts filenames as per standards
- Reduce dossier preparation time
- Reminders for regulatory events
- Reduce user dependency
In Numbers:-
- Published more than 1000 eCTD dossier
- Client in 20+ country
- 35+ success full installation
- Published more than 2000 SPLs
