Regulatory solutions

Dossier compilation & publishing solutions

eCTD publishing & submission

Regulatory Solution for dossier lifecycle management and publishing. Which create, compile, manage & publish your IND, NDA, ANDA or BLA submissions effortlessly with immaculate precision with pre-defined template structure for multiple regions.

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.

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

eCTD viewer

A web based regulatory solution to view eCTD dossier & manage large amount of sequence easily by loading a whole lifecycle of a dossier.

NeeS publishing & submission

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

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 off-the-shelf software and its effective strategic consultancy has a number of successful DMF submissions to its credit


ASMF/CEP compilation

Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy, simplifies the complexity of the XML backbone structure creation for ASMF submission.


SPL R4 creation

Sarjen pharma team creates and manages Structure Product Labeling (SPL) in XML form by using all the standard parameter for generating SPL


NeeS compilation

KnowledgeNET is a suite which provides service for NeeS dossiers creation effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.


PADER compilation

Sarjen provides predefined template and service to create PADER submission so that fast submission of adverse event can be reported to US FDA.


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…