,Archiving Services for Regulatory Publishing and Submissions - Overview
At Freyr, our Archiving Services for Regulatory Publishing and Submissions guarantee that every final eCTD submission, Gateway receipt, and health authority communication is meticulously stored and readily retrievable within our DMS, safeguarding data integrity and demonstrating eCTD archive compliance from submission to inspection.
Comprehensive Archiving of Final eCTD Submissions
Our specialized team handles the archiving of all final eCTD submissions, employing a structured DMS environment to catalog documents by submission ID, product name, therapeutic area, and relevant dates. This regulatory document management approach supports swift data retrieval for audits and lifecycle updates.
Gateway Receipts and HA Communication Archiving
Freyr archives Gateway receipts alongside corresponding eCTD packages, providing proof of submission in cases of technical issues. We also capture all health authority correspondence (emails, faxes, telephone logs) and responses, maintaining a clear, traceable record of interactions for GxP-compliant archiving.
Product Data Archiving and Long-term Data Retention for Pharma
Our services extend to long-term data retention, preserving FDA sequences and legacy non-CTD data in a historical, organized pattern. By leveraging this archival history, we enhance the efficiency of future submissions and support comprehensive pharmaceutical document archiving throughout product lifecycles.
Tailored Categorization and Folder Creation
- Documents are categorized by Product Number, Application Type, Application Number, Metadata details, and Therapeutic Area.
- Final folders are organized by country-specific application, submission type, and product category, ensuring consistent global eCTD publishing and submissions services.
Archiving Services for Regulatory Publishing and Submissions
Freyr combines deep domain knowledge with a customizable DMS platform to help clients establish efficient archiving workflows. Our expertise in regulatory publishing and submission archiving services enables our team to provide:
- Secure, customized access protocols to maintain data confidentiality
- Robust retrieval processes for rapid turnaround
- 24/7 support across IST and CEST time zones
- Cost-effective solutions without compromising quality
Partnering with Freyr delivers significant benefits for your regulatory operations:
- Rapid fulfillment of document retrieval requests
- Proven eCTD archive compliance for inspections
- Expert guidance on regulatory publishing and submissions archiving services
- Scalable, GxP-compliant archiving infrastructure
- Reduced total cost of ownership through streamlined processes
By integrating Archiving Services for Regulatory Publishing and Submissions into your regulatory strategy, Freyr ensures that your documentation is preserved, accessible, and audit-ready, supporting ongoing regulatory success.
