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A leading EU-based pharmaceutical company needed to complete an Article 61(3) Notification for the UK and EU markets under strict timelines. The project required the preparation, review, and publishing of multiple regulatory documents while meeting evolving regulatory requirements and ensuring uninterrupted product availability.
Freyr was tasked with end-to-end regulatory publishing services, including granular document-level publishing, template standardization, gap analysis, quick source document reviews, detailed version tracking, periodic quality checks, and validation using agency-recommended tools.
The collaboration resulted in error-free submissions, proactive issue resolution, and enhanced communication across teams, ensuring compliance and timely delivery.
Discover how Freyr’s expertise, streamlined processes, and dedicated workforce enabled seamless regulatory execution and helped the client maintain market authorization efficiently.
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