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…
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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…
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NeeS publishing & submission
NeeS publishing software with capabilities for publishing of NeeS submissions in multiple region with integrated document management and publishing features…
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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…
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eCTD viewer
A web based solution to view eCTD dossier & manage large amount of sequence easily by loading a whole lifecycle of a dossier…
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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…
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Testimonials

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…

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Regulatory submission services

Dossier compilation & publishing services

eCTD compilation

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

The submission process is cumbersome but KnowledgeNET-DMF service with its…
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ASMF/CEP compilation

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

SPL R4 creation

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

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

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

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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

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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…

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