Worried about PUBLISHING your Dossier in eCTD / NeeS / Paper FORMAT OR SPL in the given time-frame…

Don’t be!!! compile / publish your Dossier in required format with our Dossier-Mgmt© software seamlessly & efficiently

Educe Solutions is catering the needs of pharma industries by providing solutions in different ways since long time and have quality experience in filing significant number of submission to different regulatory authorities. our ready-to-use proficient software solution [Dossier-Mgmt©] as well as supportive technical team will help you to prepare dossier submission in eCTD as well as in NeeS format as per your requirement. Dossier-Mgmt© has a very user-friendly interface along with powerful Add-on tools which will drive you in creation, validation, correction & compilation of eCTD submission.

Our experience will for sure guarantee you in formation of fully technical compliant eCTD as well NeeS submission. our clients has successfully submitted eCTD submissions in eCTD as well as in NeeS format and seamlessly maintaining life-cycle with the help of Dossier-Mgmt©.

eCTD Compilation

All these activities are designed and developed by strictly following the regulatory guidelines which ensures the final output’s integrity to meet technical validations. You need to provide certain product information which is required while preparing eCTD submission along with content files as per Granularity. Our team is always available to support you for any type help needed or clear your queries during PDF files preparation.

Add-on tools with enriched features like PDF file properties Verification, Corrections, Auto + Quick hyperlink aids during submission process to ensure your work will be completed before time.

Before final publish activity, you can review Submission from your location.

We are geared up to cater our services for the following modules:

  • US FDA
  • EU
  • Canada
  • ZA
  • AU
  • GCC

NeeS Compilation

In the similar way to eCTD, we can provide services to Create, Verify, Correct and Publish your Dossier in NeeS format with the help of add-on tools seamlessly and efficiently.

For NeeS format we are ready to cater our services for the following Modules:

  • EU
  • GCC
  • Any other country which accepts NeeS
SPL Compilation

SPL data conversion for registration, listing and labeling, we accept raw information in the form of word document and final output is generated which is compliant to current guidelines published by US FDA.

During electronic Submissions, following add-on services are provided:

  • Hand holding while preparing documents as per granularity suggested by ICH or regional authority
  • Domain related help if required while preparing submission
  • Basic training of application if customer himself is going to prepare submission
  • Communicating with regulatory agencies as and when required
  • PDF properties verification & correction