##  [Delivering End-to-End Regulatory Support for Post-Approval Changes, Renewals, and Variations in China and Japan](/index%2Ephp/success-stories/delivering-end-to-end-regulatory-support-for-post-approval-changes-renewals-and-variations-in-china-and-japan) 

# 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.





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### 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.











![Background Icon]()  

## 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



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Partial Change Applications, Renewals, and Variations



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Supplemental CMC Submissions and Labeling Safety Activities



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Regulatory Publishing, Submission Planning, and Printing Support



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Paper-Based Submission Management



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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

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##### 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