Freyr Solutions and Services
Freyr also provided a diverse set of services that included:
- Assessed change controls, developed variation strategies, prepared variation packages, and submitted them to health authorities (HAs).
- Tracked post-approval commitments, renewal timelines, and planned necessary Regulatory submissions.
- Maintained up-to-date databases for all registered dossiers, ensuring compliance for each product.
- Coordinated with country managers and stakeholders to gather source documents and ensure timely submissions.
- Collected variation approval histories, confirmed their implementation, and followed up with manufacturing stakeholders for pending variations.
- Conducted gap analyses of supporting documents, prepared reports, and identified additional data generation requirements.
- Prepared, reviewed, and submitted CTD-format applications for initial submissions as per country-specific requirements.
- Assessed registered dossiers (e.g., USA) against requirements of other regions (e.g., EU), identified gaps, updated dossiers, and submitted to HAs.
- Identified and addressed Regulatory compliance gaps, including coordinating with R&D for required data generation.
- Identified quality gaps between manufacturing practices, current documentation, approved dossiers, and Regulatory guidelines.
- Followed up with country managers for approval statuses and communicated updates to manufacturing sites.
- Managed health authority (HA) query responses to ensure Regulatory alignment and swift resolution.
Freyr successfully managed the pharmaceutical product portfolio across the USA, LATAM, Europe, Middle East, Africa, APAC, and CIS countries, ensuring compliance with regional Regulatory requirements.
