Freyr Supported Regulatory Publishing Services in South Korea for a U.S.-Based Pharmaceutical Company

Client Overview

A U.S.-based pharmaceutical company required Regulatory operations support for oral and parenteral products intended for submission in South Korea. The company sought specialized Regulatory Publishing services to ensure compliance with South Korean guidelines.

Background

The client required comprehensive Regulatory Publishing support to facilitate eCTD submissions for oral and parenteral products in South Korea. Given the complexity of submission requirements and the need to adhere to local guidelines, the client sought a reliable partner capable of managing publishing activities while ensuring compliance, accuracy, and timely submission.

Services in Scope

Regulatory Publishing support for oral and parenteral products

eCTD publishing and submission support

Document review as per FDA PDF specifications

End-to-end publishing coordination

Quality control and compliance review

Submission tracking and version management

ESG submission support

Challenge

The client faced several challenges throughout the submission process.

The study documents required detailed review against FDA PDF specifications to identify content-related issues and ensure eCTD compatibility. This necessitated obtaining revised versions of documents that did not meet submission requirements.

In addition, the client required end-to-end publishing support, including coordination with the Contract Research Organization (CRO) for study documents and management of the process through to final ESG submission.

Frequent last-minute document changes further increased the complexity of the publishing process, creating risks related to submission timelines, version control, and overall compliance.

Solution

Freyr provided comprehensive Regulatory Publishing support throughout the submission lifecycle.

The team established a detailed tracking system to monitor all document version changes and sequence 0032 updates associated with the ANDA publishing cycle. This enabled effective management of document revisions and ensured transparency throughout the process.

Freyr also performed rigorous quality checks at every stage of the publishing workflow to verify compliance and submission readiness. Through close coordination with the CRO and proactive management of publishing activities, the team successfully supported the client's submission requirements while addressing ongoing document updates and changes.

Impact

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 support, rigorous quality reviews, and streamlined query management enabled seamless dossier submission, reduced turnaround time, and supported timely agency approvals.