Client Overview
The client is a Japan-based pharmaceutical and biotechnology company with a global presence and a diverse product portfolio. As part of its growth strategy, the organization required scalable publishing and submission support to manage increasing regulatory demands across multiple regions.
Client Background
Having partnered with Freyr for over a decade, the client relied on external expertise to support Regulatory Lifecycle Publishing (RLP), Submission Lifecycle Publishing (SLP), Lifecycle Management (LCM), and operational process enhancements. The company also planned to expand its regulatory operations footprint into additional countries while maintaining compliance with evolving Health Authority requirements.
Services in Scope
Regulatory publishing and submission support for global markets.
RLP, SLP, and LCM operational support.
SOP and work instruction development.
Publishing tool testing and User Acceptance Testing (UAT).
Publishing system data migration support.
Submission planning, publishing, and compliance management.
Publishing metrics tracking and reporting.
Challenges
Growing submission volumes required scalable publishing and operational support.
Need to maintain compliance across multiple Health Authority jurisdictions.
Expansion of regulatory operations into new geographies required standardized processes and local expertise.
Manual publishing activities created operational inefficiencies and resource constraints.
Migration to new publishing platforms required seamless transition without impacting submission timelines.
Solution
Freyr delivered end-to-end publishing and submission support through a combination of process standardization, technology enablement, and global resource expansion. The team established operational best practices, supported publishing system transitions, and ensured submissions were executed in accordance with Health Authority requirements across multiple regions.
1
Assisted in developing and maintaining regulatory operations work instructions and SOPs to standardize publishing processes.
2
Supported testing and validation of a new publishing platform, including User Acceptance Testing (UAT).
3
Facilitated migration activities to a new publishing system while ensuring business continuity.
4
Monitored and maintained publishing metrics and submission performance trends.
5
Executed publishing and submission activities in alignment with regional Health Authority requirements.
6
Expanded regulatory operations support across Canada, the UK, Poland, the Netherlands, and Ukraine to strengthen global submission capabilities.
Impact Metrics
- Achieved a 50% reduction in manual effort through optimized publishing workflows.
- Improved operational efficiency through standardized processes and technology adoption.
- Delivered high-quality submissions aligned with Health Authority expectations.
- Successfully expanded regulatory operations support across multiple global markets.
- Accelerated submission timelines, contributing to faster market entry and improved compliance outcomes.
The engagement enabled the client to enhance its global publishing and submission capabilities while maintaining regulatory compliance across diverse markets. Through process optimization, system modernization, and scalable operational support, Freyr helped establish a sustainable framework for efficient global submissions and future growth.
