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.

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
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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.

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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

Regulatory Operations support

Publishing Services

Clinical Trial Support (CTS)

Data Migration activities

SOP development and work instructions

Publishing tool support and testing

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.