KnowlegeNET is completely integrated regulatory compliant solution that complies electronic submission of dossiers in eCTD format including DMF and PADER Submissions, effortlessly for all regions and provide eCTD Service for compilation and publishing
Sarjen helps its clients accelerate innovation and increase their ROI considerably in R&D and provide quick and intuitive construction of complex electronic submission for any regulatory authority. It provides a simple and an easy-to-use user interface with multiple regional support that includes EU, US, Canada, GCC, etc with multiple parallel users
Sarjen is one of the very few software vendors vantage with intellectual and effective strategic corporate level consulting and has considerable number of successful submission of eCTDs, NeeS, eDMFs, ASMF, etc. to its credit. Geared up with an integrated validator, which provides accuracy, efficiency and robustness to the cumbersome submission process. The constant consultancy that Sarjen provides makes your submissions furthermore easy.
KnowledgeNet starts right from
We go through the whole process till final submission to Health Authorities. We even handle the Authority Submission process so as to ensure no errors and timely submissions with full accuracy. We are there with you throughout the submission life cycle of a dossier.
eCTD dossier submission
|Multi-country submissions with country specific requirements as per the compliant|
|Mapping of documents within regional submissions|
|Up-to-date eCTD versions inclusive of accurate eCTD Modules, eCTD format, eCTD Structure|
|Paper to Electronic submission|
|Other dossier submission key features click here|
US FDA eCTD submissions (ANDA,IND,NDA,BLA,AADA,DMF etc.)
Sarjen offers the following eCTD submission services to ensure US FDA acceptable eCTD enabled submissions:
- Granularity and life cycle management of documents
- US FDA specific document formatting and publishing
- Navigation Aid Management including the table of contents and hyperlinks
- Dossier assembly and compilation in eCTD format
- Paper to Electronic document conversion to provided searchable text based documents as required by US FDA
- Electronic Submissions gateway setup and administration
Pay-Per dossier service
For small sized generic companies, we provide Pay per Dossier conversion to create eCTD based submissions.
European Medicines Agency (EMA) eCTD submissions
Sarjen’s consulting team carries extensive experience in providing consulting for any eCTD submission services made in the context of a Centralized/Decentralized/National/Mutual Recognition application procedure and the subsequent maintenance of the life cycle of the application including:
- Initial application
- Supplementary information
- Follow up measures (FUMs)
- Periodic Safety Update Reports (PSURS)
Middle East GCC (Gulf Cooperation Council) eCTD submissions
Saudi Food and Drug Authority (SFDA) has start accepting dossiers in eCTD format from 03rd Jan 2015.
Sarjen with its experienced team offers eCTD submission Services for maintenance of the lifecycle of the following application for Middle East GCC (Gulf Cooperation Council) countries:
- New Marketing Authorization
- Renewal of Marketing Authorization
- Variation Type 1
- Variation Type 2
- Responses to Questions
- Periodic Safety Update Report (PSURs)
Australia (TGA) eCTD
The Drug Regulatory Authority of Australia, TGA (Therapeutic Goods Administration) has initiated the implementation of electronic application (eCTD) software which is required for validation & review of electronic applications (eCTD) for the approval of registered medicines (new chemical entity, major variations to a prescription medicine & generic medicine) on to the Australian Register of Therapeutic Goods (ARTG). Sarjen provides submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats.
Swissmedic (CH) eCTD
In Switzerland, eCTD submission is accepted as well as CTD, with CH Module 1 Specification, version 1.3 and Validation Criteria version 1.3, will be required by Swissmedic Agency (CH). Sarjen provides submissions in electronic Common Technical Document (eCTD) formats.
South Africa (ZA-MCC) eCTD
In South Africa, Medicines Control Council (MCC) initiated acceptance of eCTD submission with ZA (South Africa) Module 1 Specification, version 1.0 and Validation Criteria version 1.0. Sarjen provides fully regulatory compliant submissions of electronic Common Technical Document (eCTD).
Canada (CA-HCSC) eCTD
Sarjen provides eCTD submission Services for maintenance of the lifecycle of the following application for Canada (CA-HCSC):
- New Drug Submission (NDS)
- Supplement to a New Drug Submission (SNDS)
- Supplement to a New Drug Submission – Confirmatory (SNDS-C)
- Abbreviated New Drug Submission (ANDS)
- Supplement to Abbreviated New Drug Submission (SANDS)
Thailand (Thai-FDA) eCTD
Thai FDA (Thailand) had started accepting eCTD submission from May 2015.
Authority has mandated eCTD Submission for New Chemical Entity, New Drug, New Biological,
Biological and optional for Generic and New Generic in 2016.
In 2017 eCTD submission will be mandate for all submission.
Current Thai-FDA Module 1 Specification, version 1.0 and Validation Criteria version 1.0. is required by Thai FDA (Thailand).