Client Overview
The client is a global healthcare company with a diverse portfolio of pharmaceutical products marketed across multiple international regions. To support its established operations in Asia, the organization required dedicated regulatory expertise to manage complex post-marketing regulatory activities in China and Japan.
Client Background
As the client's portfolio expanded, the volume of regulatory maintenance activities increased significantly. Managing partial change applications, renewals, and variations across two highly regulated markets required specialized publishing expertise, deep understanding of regional requirements, and efficient operational processes. The client sought a trusted partner capable of ensuring timely and compliant submissions while reducing the burden on internal regulatory teams.
Services in Scope
Aggregate reporting support for post-marketing products.
Preparation and review of Periodic Safety Update Reports (PSURs).
Preparation and submission of Development Safety Update Reports (DSURs).
Literature surveillance and safety data analysis.
Case processing support and data reconciliation.
Regulatory compliance support across multiple therapeutic areas.
Submission management and Health Authority compliance support.
Challenges
Managing aggregate reporting requirements across multiple therapeutic areas.
Ensuring compliance with evolving global pharmacovigilance regulations.
Handling large volumes of safety data within strict reporting timelines.
Maintaining report quality, consistency, and regulatory accuracy.
Coordinating multiple stakeholders involved in safety reporting activities.
Solution
Freyr established a comprehensive pharmacovigilance support model to manage the client's aggregate reporting requirements. Through dedicated safety experts, standardized workflows, and robust quality controls, Freyr ensured the timely preparation, review, and submission of aggregate reports while maintaining compliance with global regulatory requirements.
1
Assessed existing aggregate reporting processes and identified opportunities for operational improvement.
2
Established standardized workflows for report preparation, review, and submission activities.
3
Performed literature surveillance, safety data review, and signal evaluation to support aggregate reporting.
4
Prepared and reviewed PSURs, DSURs, and other aggregate safety reports in accordance with regulatory requirements.
5
Conducted quality checks and reconciliations to ensure data accuracy and report consistency.
6
Coordinated with cross-functional stakeholders to gather safety information and address reporting requirements.
7
Managed submission timelines and compliance activities to ensure timely delivery of reports to Health Authorities.
Impact
- Achieved timely submission of aggregate reports across multiple therapeutic areas.
- Strengthened post-marketing regulatory compliance through robust reporting processes.
- Improved operational efficiency through standardized pharmacovigilance workflows.
- Enhanced report quality and consistency through rigorous review and quality control measures.
- Reduced compliance risks associated with delayed or incomplete safety reporting.
The engagement enabled the client to strengthen its post-marketing pharmacovigilance operations while maintaining compliance across a complex global regulatory environment. Through comprehensive aggregate reporting support, standardized processes, and dedicated safety expertise, Freyr helped the organization ensure ongoing regulatory compliance and patient safety across its product portfolio.
