Accelerate and Streamline

Regulatory Submissions from Planning to Tracking

The Freyr SUBMIT PRO is an electronic Common Technical Document (eCTD) publishing Software that eases the eCTD submission process. It is based on how effective an eCTD software is to create, validate, track, publish, view, and manage the entire document life cycle, including complete clinical/pre-clinical research data. Furthermore, the functionality to be considered is the eCTD Software’s versatility to region-specific submission formats under strict eCTD guidelines and compliance timelines. It might be time-consuming at times to manage or convert the existing data into different region-specific eCTD templates/submission formats.

eCTD templates/submission formats

  • Investigational New Drugs (INDs)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Marketing Authorization Applications (MAA)
  • New Drug Submission (NDS)
  • Abbreviated New Drug Submission (ANDS)
  • Drug Master File (DMF)
  • Active Substance Master File (ASMF)
  • Investigational Medicinal Product Dossier (IMPD)
  • Biological License Applications (BLAs)
  • EAEU Electronic Submission

In such scenarios, life sciences organizations should look for a robust and effective eCTD tool/publishing & submission software for faster, compliant and seamless submissions. Freyr, with its advanced eCTD software - Freyr SUBMIT PRO, effectively handles clients’ end-to-end global publishing and submission requirements.

Freyr SUBMIT PRO also supports EAEU’s (Eurasian Economic Union) electronic submission format. It is one of the first electronic submission software to support and implement electronic submissions in the EAEU region.

  • eCTD Templates for all Regions
  • Inbuilt Validator to Check Submission Compliance
  • Health Authority Query Management
  • NeeS Submission Support

Freyr SUBMIT PRO Expertise

  • Collaborative Submission Preparation & Review
  • Easy Interface for Submission Lifecycle Management & Features like CSR
  • Inbuilt PDF Bookmark and Link Manager
  • Supports Integration with Leading EDMS
  • eCTD Viewer Capabilities to Review the Submission Lifecycle of all Regions
  • Fast & Easy Compilation
  • Light Weight Web-based Application
  • FDA 21 CFR Part 11 and EU GMP Annex 11 Compliant

Freyr SUBMIT PRO Features

  • Inbuilt Validator
  • Inbuilt eCTD Viewer
  • Inbuilt PDF Manager
  • Import Utility
  • Module Cloning
  • Cross Reference Functionality
  • Robust audit trail & reporting mechanism
  • A web-based eCTD software
  • Lightweight, Flexible and Robust
  • Advanced notification system

Know More
About Freyr SUBMIT PRO

www.ectdtool.com

Workflow

 

Create Assembly

  • Create an assembly
  • Provide regional metadata
  • Upload documents
 

Compile

  • Create assembly in compile path with xml backbone and folder structure
 

Validate

  • Regional level validation
  • ICH level validation
  • PDF level validation
 

Publish

  • Submission ready package
  • Dispatch to agency (using various agency gateways like ESG, CESP, etc.)

eCTD Viewer

  • eCTD viewer to view the entire application in different views - Table of Content View, Sequence, Regulatory Activity, Folder and Study view