Freyr Digital software

Freyr SUBMIT PRO is an advanced electronic Common Technical Document (eCTD) submission software, designed to streamline the regulatory submission processes across the pharmaceutical and life sciences industries. The platform integrates multiple functionalities such as an intelligent validator tool, which ensures precise compliance with eCTD standards, and an automated publishing workflow that reduces the manual workload. It is compatible with leading electronic Document Management Systems (eDMS) and supports seamless data migration and document reuse, ensuring both efficiency and accuracy. Freyr SUBMIT PRO is compliant with 21 CFR Part 11 regulations, offering a touchless submission process and a user-centric interface. Its subscription plans are flexible, offering features suitable for varying needs, from starter packs to enterprise-level services, making it a comprehensive solution for companies aiming to simplify and enhance their regulatory compliance efforts.

Freyr rDMS is a comprehensive cloud-based solution designed to simplify and manage the complexities of regulatory document handling within the life sciences sector. The software provides end-to-end capabilities for creating, managing, and archiving data and documents while ensuring strict compliance with industry regulations. Key features include insightful dashboards for detailed reporting, advanced administrative functions, and support for multiple languages, making it suitable for global operations. It supports seamless integration with existing systems, allowing for parallel review and collaborative editing without restrictions on document uploads. The solution offers versatile deployment options, ensuring that organizations can choose a setup that meets their specific operational needs. Additionally, Freyr rDMS includes quality management system (QMS) integration and an inbuilt audit trail for comprehensive document monitoring. This software not only enhances efficiency through automated workflows but also underscores security and organization in document management processes, helping companies tackle compliance challenges with ease.

Freyr SPL-SPM is designed to address the challenges associated with Structured Product Labeling (SPL) and Structured Product Monograph (SPM) submissions. By focusing on automation and compliance, this software ensures adherence to mandatory standards and aids in managing complex submission lifecycles efficiently. It boasts features like unified reporting, centralized storage, and seamless versioning, facilitating streamlined electronic drug processes. The integration with Electronic Document Management Systems (EDMS) enhances workflow management, and the system's built-in validator ensures compliance with health authority protocols. Freyr SPL-SPM is invaluable for organizations facing demanding SPL-SPM revisions and compliance issues, providing a central repository for data element management and allowing for bulk data migration, ultimately aiming to simplify and accelerate the submission process with tailored solutions for each user's needs.

Freyr Artwork 360 is designed to streamline and enhance the management of artwork in the life sciences industry. It supports the entire artwork development lifecycle, from initiation to printing, ensuring timely delivery and compliance with regulatory requirements. The platform facilitates collaboration among stakeholders, enhancing oversight throughout every phase and is accessible 24/7 from any location. Key features include customizable workflow design, which allows adaptation to specific project needs, and robust version control to maintain the integrity and traceability of document versions. Additionally, the platform offers customizable reporting for insightful analysis and allows for consistent process management. Freyr Artwork 360 enables synchronized artwork creation and approval processes, ensuring that design teams maintain uniform designs across multiple brand portfolios and adapt seamlessly to evolving packaging and labeling regulations.

Freyr SPAR is a comprehensive Regulatory Information Management System (RIMS) designed to address the complexities of global regulatory landscapes. The system facilitates seamless integration, tracking, and optimization of regulatory data. With extensive lifecycle management capabilities, Freyr SPAR provides a unified platform for regulatory documentation and metadata management. Its smart tools, like the wizard and search functionalities, enhance user interaction, while customizable reporting and dashboards offer tailored insights. The intuitive, web-based interface ensures ease of use. Freyr SPAR supports regulatory data integration and SPOR integration for a streamlined regulatory lifecycle oversight. It fosters team collaboration by maintaining data consistency and clarity, which is crucial for compliance strategies. The system is designed to tackle diverse information management needs and evolving regulatory requirements, making it suitable for organizations looking to harmonize their regulatory landscape efficiently.