eCTD Publishing & Submission Region Wise Dossier Management Dossier Lifecycle Management Product Wise Dossier Lifecycle Management eCTD Viewer Effectively work for Visualizing eCTD Lifecycle Operations Regulatory Compliance Establish Framework for Regulatory Compliance Regulatory Information Management
System
Effective Decision Making About Product Portfolios
Regulatory Solution
Dossier Compilation & Publishing Solutions
01
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…

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02
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…


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03
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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04
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...

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05
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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06
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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Regulatory submission services
Dossier Compilation & Publishing Solutions

Leverage our experience in creating eCTD, ASMF, DMF, CTA, IND, MAA and many more…

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eCTD publishing and compilation

eCTD publishing and compilation

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

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DMF publishing and compilation

DMF publishing and compilation

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

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ASMF/CEP publishing and compilation

 ASMF/CEP publishing and compilation

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

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SPL R4 creation

SPL R4 creation

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

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NeeS compilation

NeeS compilation

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

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PADER 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

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…

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