Client Overview
A China-based pharmaceutical company required support for filing a comprehensive Drug Master File (DMF) application with the US FDA as part of its global market expansion strategy. The client needed assistance in managing frequent document revisions, ensuring submission readiness, maintaining version control, and meeting strict FDA Regulatory submission timelines while complying with US FDA DMF requirements, electronic submission standards, and Regulatory compliance expectations.
Background
As part of its global Regulatory strategy, the client planned to submit a Drug Master File (DMF) to the US FDA to support pharmaceutical product commercialization and market access initiatives. However, the submission involved extensive documentation, frequent content revisions, complex publishing requirements, and strict Regulatory compliance obligations.
The organization required an experienced Regulatory Affairs and Regulatory Publishing partner capable of managing document publishing, quality control, submission tracking, version management, and FDA-specific formatting requirements while ensuring timely submission and compliance with global Regulatory standards.
Services in Scope
DMF Application Publishing and Submission Support
Regulatory Submission Roadmap Development
Granular Document-Level Publishing
Version Control and Change Tracking Management
Quality Control (QC) and Rosetta Review Support
FDA Submission Compliance Management
Submission Validation and Quality Review
Regulatory Project Coordination and Submission Tracking
Challenge
Tight Regulatory Submission Timelines The client faced challenges in preparing and submitting the DMF application within aggressive timelines while maintaining submission quality and Regulatory compliance.
Managing Frequent Document Revisions Continuous document updates and incremental revisions created complexities in document version control, submission tracking, and publishing management.
FDA File Size and Page Count Requirements The submission required document splitting, formatting, hyperlinking, and publishing in accordance with US FDA submission requirements, file size limitations, and technical document standards.
Complex Documentation Compilation Compiling Manufacturing Batch Records (MBRs), supporting reports, and technical documentation added to the complexity of submission preparation and quality review activities.
Solution
1
Regulatory Submission Roadmap Development
Created a detailed submission roadmap to streamline publishing activities, improve coordination, and ensure timely execution of all Regulatory submission milestones.
2
Granular Document-Level Publishing
Performed document-level publishing, formatting, hyperlinking, bookmarking, and quality checks to align submission content with FDA Regulatory requirements.
3
Version Tracking and Change Management
Developed detailed trackers and version control mechanisms to manage document revisions and maintain complete visibility throughout the publishing lifecycle.
4
Comprehensive Quality Review
Implemented a two-stage quality control process, including Rosetta review, to ensure submission accuracy, data integrity, and compliance with FDA publishing standards.
5
Submission Validation and Delivery
Successfully delivered a 4 GB DMF submission package with zero validation issues while ensuring complete Regulatory compliance and submission readiness.
Impact
Freyr's support enabled the client to successfully complete a complex US FDA DMF submission while improving efficiency, compliance, submission quality, and Regulatory readiness.
Regulatory Excellence
- Ensured full compliance with US FDA DMF submission requirements
- Delivered a submission package with zero validation issues
- Maintained transparency throughout the Regulatory submission process
- Strengthened submission quality and Regulatory compliance
Faster Submission Execution
- Supported timely DMF filing despite aggressive timelines
- Enabled efficient management of document revisions, publishing, and validation activities
- Accelerated submission readiness and Regulatory execution
Operational Efficiency
- Implemented a 24x7 follow-the-sun global delivery model
- Improved coordination, document tracking, and submission management
- Streamlined Regulatory publishing, validation, and quality review workflows
Business Value
- Achieved a 70% increase in cost efficiency
- Accelerated the Regulatory review and approval process
- Enhanced global Regulatory operations and submission management capabilities
- Enabled the client to gain a competitive advantage through timely FDA submission execution
