Business Imperatives

  • An USA based client sought Regulatory operations support for oral & parenteral products in South Korea.
  • The company required Regulatory Publishing services with South Korea guidelines.

Objectives

To ensure a compliant and timely eCTD submission for oral and parenteral products in South Korea by providing end-to-end Regulatory Publishing support aligned with local guidelines.

Problem Statement

The client faced the following challenges:

  • Reviewing of all the study documents as per FDA (Food and Drug Administration) PDF specification including content issues and getting revised version of all the eCTD incompatible documents
  • Taking care of end-to-end publishing activity from coordinating with CRO (Contract Research Organization) for study documents to final ESG (Electronic Submissions Gateway) submission
  • Last minute document changes

Freyr Solutions and Services

Freyr Solutions and Services

Freyr also provided a diverse set of services that included:

  • Detailed tracker creation to track all the version changes and 0032 sequences for ANDA made through publishing cycle
  • Rigorous quality check performed at every step of the process

Freyr successfully ensured a valid and error-free submission by performing a comprehensive gap analysis of the dossier, coordinating with the CRO, and managing original ANDA and DMF applications. Proactive publishing, rigorous quality checks, and streamlined query management enabled seamless dossier submission—reducing turnaround time and supporting timely agency approvals.

  • Provided valid submission, compliant to the agency requirement with zero errors and warnings
  • Reducing overall TAT (Turnaround Time)
  • Cost benefits, upwards of 70%