Delivering End-to-End Regulatory Support for Post-Approval Changes, Renewals, and Variations in China and Japan

Providing comprehensive Regulatory Affairs support in China and Japan for post-approval changes, renewals, variations, supplemental CMC submissions, labeling safety activities, Regulatory publishing, and submission management, while ensuring compliance, quality, operational efficiency, and alignment with local Health Authority requirements.

40+

Regulatory submissions completed across China and Japan

100%

KPI and SLA compliance achieved

<1-day

turnaround time (TAT) delivered for five priority submissions

Client Overview
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Client Overview

A global healthcare company specializing in gynecological products focused on women's health required comprehensive Regulatory Affairs and Regulatory Operations support for: 

  • Partial Change Applications
  • Renewals
  • Variations
  • Supplemental CMC Submissions
  • Labeling Safety Activities 

Having previously partnered with Freyr for Pharmacovigilance (PV), local Regulatory support, and in-country Regulatory expertise in China and Japan, the client sought additional assistance for Regulatory Publishing, Submission Management, and Lifecycle Maintenance activities. 

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Background

As the client's product portfolio expanded across China and Japan, managing Regulatory lifecycle management activities, post-approval variations, renewals, and change control submissions became increasingly complex. The organization needed a trusted Regulatory partner to support a broad range of lifecycle activities while navigating evolving NMPA and PMDA Regulatory requirements, local compliance obligations, and operational challenges.

The client required support for multiple submission types, including partial change applications, renewals, variations, supplemental CMC submissions, and labeling safety updates. Additionally, the company needed assistance with Regulatory publishing, dossier preparation, submission planning, and Regulatory submission execution to maintain compliance and ensure timely approvals.

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Services in Scope

Partial Change Applications, Renewals, and Variations

Supplemental CMC Submissions and Labeling Safety Activities

Regulatory Publishing, Submission Planning, and Printing Support

Paper-Based Submission Management

Local Regulatory Support, Resource Training, and Compliance Management across China and Japan

Challenge
Challenge

Challenge

Challenge

Developing Region-Specific Regulatory Processes The client required the development of Standard Operating Procedures (SOPs), work instructions, and operational workflows to support Regulatory submission planning, publishing, and printing activities across new markets while maintaining compliance with local Health Authority expectations. 

Challenge

Local Language Submission Requirements Health Authorities in China and Japan required submissions in local languages, creating challenges in identifying qualified local Regulatory experts and ensuring submission accuracy and compliance. 

Challenge

Paper-Based Submission Complexity Managing paper-format submissions increased operational workload, extended submission timelines, and introduced process inefficiencies that affected Regulatory Operations. 

Challenge

Managing Multiple Post-Approval Submission Types Coordinating renewals, variations, supplemental CMC submissions, and labeling safety activities simultaneously while maintaining Regulatory compliance, quality standards, and submission timelines placed significant pressure on internal Regulatory Affairs teams. 

Challenge

Solution

1
Challenge
Comprehensive Lifecycle Management Support 

Provided end-to-end support for: 

  • Partial Change Applications
  • Renewals
  • Variations
  • Supplemental CMC Submissions
  • Labeling Safety Activities 

ensuring timely, compliant, and efficient execution of all Regulatory activities. 

2
Challenge
End-to-End Regulatory Publishing and Submission Services

Managed submission planning, publishing, printing, and submission activities to support efficient Regulatory Operations and Health Authority compliance across China and Japan. 

3
Challenge
Tailored Regional Regulatory Strategy

Developed country-specific Regulatory submission approaches aligned with NMPA and PMDA requirements, ensuring smooth execution and compliance with local market expectations. 

4
Challenge
Resource Enablement and Training

Trained additional Regulatory resources and established standardized processes to improve delivery consistency, submission quality, and operational scalability. 

5
Challenge
High-Volume Submission Management

Successfully executed more than 40 Regulatory submissions while maintaining compliance standards, submission quality, and client-defined timelines.

Challenge

Impact

Freyr's support enabled the client to streamline Regulatory lifecycle management, Regulatory publishing, submission management, and post-approval change control activities across China and Japan, improving operational efficiency and compliance performance.

Challenge
Regulatory Excellence 
  • Achieved 100% KPI compliance
  • Achieved 100% SLA compliance
  • Maintained submission quality and Regulatory adherence
  • Strengthened compliance with local Health Authority requirements 
Challenge
Faster Submission Timelines 
  • Delivered less than one-day turnaround time for five priority submissions
  • Accelerated Regulatory publishing and submission execution
  • Improved submission readiness and operational responsiveness 
Challenge
Operational Efficiency 
  • Successfully managed more than 40 submissions across China and Japan
  • Reduced the operational burden on internal Regulatory Affairs teams
  • Improved scalability for future lifecycle management and post-approval activities 
Challenge
Business Value 
  • Enhanced Regulatory readiness across key Asian markets
  • Improved Regulatory submission planning and coordination
  • Enabled the client to focus internal resources on strategic Regulatory priorities
  • Supported sustainable Regulatory compliance and business growth in China and Japan