##  [Accelerating Regulatory Operations and Global Resource Expansion Across Multiple Markets](/success-stories/accelerating-regulatory-operations-and-global-resource-expansion-across-multiple-markets) 

# Accelerating Regulatory Operations and Global Resource Expansion Across Multiple Markets

Providing Regulatory Operations support, Publishing Services, Clinical Trial Support (CTS), data migration activities, and SOP development to accelerate Regulatory submissions across existing and new markets.





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### 50%



reduction in manual efforts







### Global resource



expansion across Canada, UK, Poland, Netherlands, and Ukraine







### High-quality



submissions compliant with Health Authority standards













![Client Overview]()



![Icon]()  

## Client Overview



A Japanese pharmaceutical and biotechnology company with a decade-long partnership with Freyr required RLP, SLP, and LCM support, along with SOP creation. The client also sought global resource expansion across multiple countries, including Canada, UK, Poland, Netherlands, and Ukraine.











![Background Icon]()  

## Background



The client sought to accelerate Regulatory submissions in existing and new markets by leveraging Freyr Solutions' expertise in Regulatory Operations, including Publishing Services, Clinical Trial Support (CTS), and data migration activities.





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## Services in Scope



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Regulatory Operations support



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Publishing Services



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Clinical Trial Support (CTS)



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Data Migration activities



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SOP development and work instructions



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Publishing tool support and testing



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Submission support across global markets















![Challenge]()



![Challenge]()

## Challenge



![Challenge]()

**Quality Compliance Requirements** Previously published reports such as CSRs and CSR equivalents required Quality checking to meet Health Authority requirements.





![Challenge]()

**Submission Support Requirements** Submissions for Europe lacked attention.





![Challenge]()

**Limited Local Expertise** Not enough local experts were available at the site.















![Challenge]()

## Solution



1

![Challenge]()

##### Global Regulatory Operations Support

Freyr offered comprehensive support as an "extended arm" to the client, providing a staffing model for Publishing Services across the US, Germany, and Freyr's India office.





2

![Challenge]()

##### Clinical Trial and Data Migration Support

Additional Clinical Trial Support (CTS) was provided, along with support for Data Migration activities.





3

![Challenge]()

##### SOP Development and Publishing System Support

Assisted in developing assigned Regulatory Operations work instructions/SOPs. Supported the testing of a new Publishing tool and participated in Publishing tool User Acceptance Testing (UAT). Assisted in data migration to a new Publishing System.





4

![Challenge]()

##### Submission Management and Compliance Support

Maintained Publishing metrics and trends for all delivered submissions. Helped navigate submissions as per Health Authority requirements.











![Challenge]()

## Impact



Freyr's interventions led to significant improvements in the company's submission processes, resulting in faster and more efficient market entry. The collaboration also bolstered the company's Regulatory compliance and operational efficiency.



![Challenge]()

##### Operational Efficiency 

- Achieved a 50% reduction in manual efforts, enhancing efficiency.





![Challenge]()

##### Compliance Excellence 

- Ensured high-quality submissions compliant with Health Authority standards.





![Challenge]()

##### Global Expansion Support 

- Successfully expanded Regulatory Operations to new markets, ensuring local expertise and compliance.





![Challenge]()

##### Business Outcome 

- Faster and more efficient market entry.
- Improved Regulatory compliance.
- Enhanced operational efficiency.