Regulatory solutions

Dossier compilation & publishing solutions

eCTD 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 submission…
NeeS publishing & submission
NeeS publishing software with capabilities for publishing of NeeS submissions in multiple region with integrated document management and publishing features…
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…
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…


Sree Vadlamudi (Medline Industries, Inc.)

Of the handful of options available for internally hosted eCTD solutions, Sarjen System’s KnowledgeNet is a smartly designed interface with an attractive priceand the least infrastructure requirements…


Regulatory submission services

Dossier compilation & publishing services

eCTD compilation

eCTD dossier compilation and life cycle management support and management of submissions…

DMF compilation

The submission process is cumbersome but KnowledgeNET-DMF service with its…

ASMF/CEP compilation

Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy…
Regulatory submission services

SPL R4 creation

Sarjen pharma team creates and manages Structure Product Labeling (SPL) in XML form by using all…

NeeS compilation

KnowledgeNET is a suite which provides service for NeeS dossiers creation effortlessly with…

PADER compilation

Sarjen provides predefined template and service to create PADER submission so that fast submission…

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…