Client Overview
The client is a Japanese midsize global pharmaceutical and biotechnology company with an expanding presence across international markets. To support ongoing regulatory activities in the US and Canada, the organization required a strategic publishing partner capable of delivering scalable submission support while maintaining compliance and operational efficiency.
Client Background
Having collaborated with Freyr for more than three years, the client sought continued support for Original, Lifecycle Management (LCM), and SPL/SPM submissions. The organization faced resource instability due to high attrition rates and required expert guidance to navigate Canadian regulatory requirements for New Drug Submissions (NDS) and Structured Product Monograph (SPM) submissions.
Services in Scope
Publishing support for Original, LCM, and SPL/SPM submissions.
End-to-end publishing and submission management for US and Canadian markets.
Process consulting and publishing workflow optimization.
Hybrid onshore-offshore staffing support.
Submission planning, publishing, and compliance management.
Regulatory operations best-practice implementation and maintenance.
Challenges
High attrition rates created instability in resource availability and submission support.
Lack of clarity around Canadian NDS and SPM submission requirements.
Existing publishing processes required standardization and optimization.
Need for round-the-clock operational support to manage submission timelines efficiently.
Risk of delays and compliance issues due to evolving regulatory requirements.
Solution
Freyr developed and implemented a scalable hybrid staffing model that combined onshore and offshore resources to provide 24/7 publishing support. In parallel, the team established standardized publishing processes and best practices for US and Canadian submissions, enabling greater operational efficiency, compliance, and cost optimization.
1
Assessed existing publishing operations and identified opportunities for process optimization.
2
Defined and implemented standardized publishing workflows and best practices for US and Canadian submissions.
3
Established a scalable hybrid staffing model leveraging both onshore and offshore resources.
4
Provided comprehensive publishing support for Original, LCM, and SPL/SPM submissions.
5
Supported the client's first Canadian NDS and SPM submissions through expert regulatory guidance and execution.
6
Maintained publishing processes and operational controls to ensure continued compliance and submission quality.
Impact Metrics
- Achieved 100% on-time submission delivery.
- Realized more than 50% cost savings through the hybrid staffing model.
- Recorded zero Health Authority rejections.
- Improved publishing process efficiency and operational scalability.
- Strengthened compliance and submission quality across US and Canadian markets.
The engagement transformed the client's publishing operations by introducing a scalable, cost-effective support model capable of meeting growing regulatory demands. Through strategic process consulting, expert publishing support, and a robust hybrid staffing framework, Freyr enabled sustained submission excellence while improving efficiency, compliance, and business continuity across key global markets.
