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Submission Management
Freyr SUBMIT PRO - eCTD Submission 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 - Electronic Regulatory Document Management Software
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.
