System
Dossier Compilation & Publishing Solutions
eCTD/NeeS publishing & submission
Dossier lifecycle management and publishing solution which create, compile, manage & publish your IND, NDA, ANDA or BLA submissions effortlessly with immaculate precision with…
Regulatory Information Management System
Solution to capture life cycle of drug & its information for well-organized pharma regulatory work flow and to increase speed & quality of regulatory…
CTD/Paper publishing & submission
Paper submission module is single platform to manage, register, review, archive, publish CTD/paper dossier with easy to use screens and having multiple region pre-defined structure…
Query Management
QM is a unique feature which helps in tracking creation, review and updates of submissions, amendments, Regulatory Agency’s query response along with...
eCTD viewer
A web based solution to view eCTD dossier & manage large amount of sequence easily by loading a whole lifecycle of a dossier…
eCTD submission on-cloud
Gateway of electronic submissions. A ready to use solution for eCTD dossier creation and publishing on cloud with high level of documents security…
Dossier Compilation & Publishing Solutions
eCTD publishing and compilation
DMF publishing and compilation
ASMF/CEP publishing and compilation
SPL R4 creation
NeeS compilation
PADER compilation
List Of Services
eCTD/eDMF documents preparation, review
eCTD/eDMF dossier validation
Conversion of SPL R3 to R4
ER, NDC and GDUFA self registration
US FDA ESG gateway submission
ESG setup consulting
Reply to regulatory queries
Prepare SmPC and pack information leaflet
End-to-end regulatory services covering…
Pharma regulatory strategy
Dossier preparation
Compilation of dossier (eCTD/eDMF)
Submission to regulatory authorities
Product life cycle management
Regulatory medical writing
Regulatory guidelines consulting
Regulatory Information Management System (RIMS)
Regulatory Information Management System (RIMS) is a life cycle process of drug (starting to end), from which organizations are effectively and efficiently developing and handling new and existing products information before, during and after drug registration…
