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Publishing and Submission

Overview

Abbreviated New Drug Application (ANDA) publishing and submission must be made in accordance with the standard Regulatory procedures and formats as recommended by the USFDA. The generic applicant is required to submit all documents and other information in a CTD format and due to the enormous amount of information present in the ANDA, the USFDA has made it mandatory for all the manufacturers to adopt the eCTD submission process instead of paper submission for a faster Regulatory review process.

Many industries face a challenge in compiling and managing vast information to be compiled during generic medicine publishing and submission. Therefore, effective strategic planning and prerequisites should be taken into consideration before along with a proper understanding of the FDA’s requirements and latest updates on the

Freyr, with qualified Regulatory publishing and submission experts and a robust and submission software, helps clients to overcome the Regulatory submission challenges to ensure error-free submissions and timely approval of generic medicines. We provide our clients with various models of service depending upon their requirements:

  • Freyr technology and Freyr resource support
  • Client technology and Freyr resource support
  • Client technology and client resource support

Freyr Expertise

  • 01

    End-to-end generic medicine application Regulatory submission and publishing including submission level and document level publishing activities

  • 02

    Regulatory submissions in the eCTD format

  • 03

    Conducting multi-level QC check and review of documents before submitting to the clients/HA

  • 04

    Continuous project monitoring

  • 05

    eCTD submission strategy right from the initial submissions to lifecycle management in align with ANDA submission requirements of the HA

  • 06

    Creation of detailed tracker for the changes made throughout the publishing lifecycle

  • 07

    Freyr SUBMIT PRO - Regulatory publishing and submission tool

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