Archiving Services for Regulatory Publishing and Submissions

At Freyr, we understand the critical importance of maintaining comprehensive and accurate archives of Regulatory submissions. Our Archiving Services are designed to ensure that all final eCTD submissions, along with Gateway Receipts, and health authority communications are meticulously stored in Document Management Systems (DMS) within their respective folders. This systematic approach to archiving not only secures the integrity of your submission data but also streamlines the retrieval process for future reference and Regulatory inspections.

Archiving of All Final eCTD Submissions

Our team of experts specializes in the archiving of all final eCTD submissions, ensuring that every aspect of your submission is preserved in its original form. We maintain a structured and secure environment within our DMS, where final submissions are categorized and stored in a way that facilitates easy access and management. This includes the careful organization of submissions by submission ID, submission type, product name, therapeutic area, and dates, allowing for quick retrieval when needed.

Gateway Receipts Archiving in DMS

Freyr's archiving services extend to the preservation of Gateway receipts. These Receipts are critical proof of submission and are archived in the DMS alongside the corresponding eCTD submissions. If any unforeseen technical issues arise this can act as proof that submissions have been made to HA. By keeping these receipts in their respective folders, we provide a comprehensive record of the submission, from the initial application to the current Regulatory activities and confirmation of receipt by the health authority of the respective submissions.

HA Communication Archiving

Ensuring that all relevant information is preserved for Regulatory compliance and future reference. This includes the archiving of HA incoming correspondence, such as emails, faxes, and telephone communication logs, and the respective responses that have been provided on behalf of the organization, per product. By maintaining a detailed archive of all interactions with health authorities, we help you keep a clear and traceable record of the Regulatory journey of each product.

Product Data Archiving

Submissions or sequences made to the FDA are stored in a well-organized, historical pattern. This systematic approach ensures that each submission, from the first to the most recent, is cataloged promptly. Maintaining this detailed record is crucial for performing any lifecycle operations related to future submissions for the product.

Our team leverages this historical data to enhance the efficiency and accuracy of subsequent submissions, ensuring compliance with Regulatory standards and facilitating smooth product lifecycle management.

Archiving Legacy non CTD Data into DMS

In addition to current submissions and correspondence, Freyr also provides services for archiving all old data into the DMS. This historical data is invaluable for understanding the Regulatory lifecycle of a product and can be crucial during audits or when referencing past submissions. Our team ensures that this data is transferred to the DMS with the same level of care and organization as current submissions, maintaining the integrity and accessibility of your Regulatory archives.

Categorization and Folder Creation:

• We categorize documents based on Product Number, Application Type, Application Number, Metadata Details, and Therapeutic Area, tailored to your specific requirements.
• Each document is meticulously organized into the final folder based on country-specific application, submission type, and product category.

Freyr's archiving services are an integral part of our Regulatory publishing and submission offerings. We are committed to ensuring that your Regulatory documentation is preserved in a secure, organized, and compliant manner, providing peace of mind, and supporting your ongoing Regulatory success.