knowledgenet.sarjen.comeCTD, CTD, dossier submission and management software, DMS,

SPL sarjen@sarjen.com HomeCompany Overview Testimonials Services Overview Regulatory submissions eCTD Drug Master File (DMF) Active Substance Master File (ASMF)/CEP NeeS SPL R4 Periodic Adverse Drug Experiences Report (PADER) Regulatory services Solutions eCTD publishing & submission NeeS publishing & submission CTD/Paper publishing & submission Regulatory Information Management System (RIMS) eCTD viewer eCTD submission on-cloud Query Management (QM) Compliance Knowledge Bank Blog Webinar Regulatory links Contact us Search for: HomeCompany Overview Testimonials Services Overview Regulatory submissions eCTD Drug Master File (DMF) Active Substance Master File (ASMF)/CEP NeeS SPL R4 Periodic Adverse Drug Experiences Report (PADER) Regulatory services Solutions eCTD publishing & submission NeeS publishing & submission CTD/Paper publishing & submission Regulatory Information Management System (RIMS) eCTD viewer eCTD submission on-cloud Query Management (QM) Compliance Knowledge Bank Blog Webinar Regulatory links Contact us 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… Read More 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… Read More 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… Read More 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... Read More 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… Read More 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… Read More Regulatory submission services Dossier Compilation & Publishing Solutions Leverage our experience in creating eCTD, ASMF, DMF, CTA, IND, MAA and many more… Read More eCTD publishing and compilation The submission process is cumbersome but KnowledgeNET-DMF service with its… Read More DMF publishing and compilation Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy… Read More ASMF/CEP publishing and compilation Sarjen pharma team creates and manages Structure Product Labeling (SPL) in XML form by using all… Read More SPL R4 creation The submission process is cumbersome but KnowledgeNET-DMF service with its… Read More NeeS compilation Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy… Read More 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 More 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 More 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… More Global Dossier Publishing & Management Software Download Brochure Copyright © 2024 Sarjen Systems Pvt. Ltd. All rights reserved Sitemap Linkedin-in Instagram Youtube Facebook-f Book a Demo Name: * Email: * Contact Number: * Organisation Name: * × Book a Demo Required fields are marked * Area Of Interest CTD/Paper Submission Annual Product Review eTrail Master File eCTD Dossier Life Cycle Drug Dossier and Data Tracker Regulatory Processes Consultancy Regulatory Processes - Software Validation Regulatory Submissions - eDMF Regulatory Submissions - eCTD Regulatory Submissions - NeeS Regulatory Submissions - SPL R4 Book a...