##  [Cut FDA Submission Timelines by 60% with Freya Fusion, Freyr’s AI-powered, automation-first submission platform.](/medicinal-products/cut-fda-submission-timelines-by-60-percent-with-freya-fusion-freyrs-ai-powered-automation-first-submission-platform) 

# Cut FDA Submission Timelines by 60% with Freya Fusion, Freyr’s AI-powered, automation-first submission platform.

With built-in intelligence for FDA eCTD publishing and validation, Freya Fusion helps you eliminate manual errors, streamline workflows, and achieve faster approvals — so your teams can focus on strategy, not spreadsheets. Launch smarter. Launch faster. Launch with Freya Fusion!

**Let Freya Fusion Shorten Your FDA Path**



#### Get Faster FDA Approvals









### Reduced

Submission Timelines:   
90 days → 30 days



 

### 40%

Reduction in   
QC Efforts



 

### 99.8%

Accuracy   
Improvement



 

### Adopted by

Top US Pharma   
Innovators











## Why Choose Freya Fusion?

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##### eCTD Automation

End-to-end automation for eCTD-ready submissions — from dossier assembly to FDA validation — in a single click.



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##### QC Automation

Eliminate manual review fatigue with built-in AI QC that validates hyperlinks, bookmarks, metadata, and XML structures instantly.



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##### FDA ESG-Ready Output

Generate validated, ESG-ready submissions with automatic tracking and versioning — no rework, no delays, no manual errors.



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##### Cloud-Based, Secure & Compliant

Enterprise-grade security, audit trails, and role-based access ensure compliance at every stage.





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## Frequently Asked Questions

#### [1. What is Freya Fusion and how does it support FDA submission automation?](#collapseOne)



Freya Fusion is Freyr’s AI-driven FDA submission automation platform that simplifies and accelerates eCTD publishing, validation, and submission processes. It automates manual tasks, ensures error-free regulatory submissions, and enables faster drug approvals through built-in intelligence and cloud-based efficiency.







#### [2. How does Freya Fusion reduce FDA submission timelines?](#collapseTwo)



By leveraging automation and AI validation, Freya Fusion can help reduce submission timelines by up to 60% — transforming a 90-day NDA or BLA submission process into just 30 days. The platform eliminates repetitive manual QC, integrates with DMS systems, and streamlines every stage of eCTD preparation.







#### [3. What makes Freya Fusion the best automation tool for life sciences companies?](#collapseThree)



Freya Fusion offers end-to-end automation, AI-based QC for bookmarks, hyperlinks, and metadata, and ESG-ready FDA outputs with zero manual rework. With 99.8% accuracy and a proven track record across top global pharma clients, it’s the industry benchmark for regulatory submission excellence.







#### [4. Can Freya Fusion manage global eCTD and lifecycle submissions?](#collapseFour)



Yes. Freya Fusion supports complete eCTD lifecycle management, covering IND, NDA, ANDA, BLA, and post-approval submissions like Annual Reports, Renewals, and Variations. It complies with multiple regulatory standards including FDA v4.0, EMA, Health Canada, TGA, PMDA, and EAEU formats.







#### [5. Is Freya Fusion FDA 21 CFR Part 11 compliant and secure?](#collapseFive)



Absolutely. Freya Fusion is built for FDA 21 CFR Part 11 compliance, offering robust audit trails, access controls, and electronic signatures. It’s hosted on ISO 27001-certified cloud infrastructure, ensuring the highest standards of data security and regulatory compliance.







#### [6. How does Freya Fusion integrate with existing regulatory systems?](#collapseSix)



Freya Fusion seamlessly integrates with Document Management Systems (DMS) and Regulatory Information Management (RIM) platforms. Its open architecture allows data synchronization, real-time submission tracking, and unified dashboards — all while maintaining regulatory traceability.







#### [7. Who uses Freya Fusion for FDA eCTD submissions?](#collapseSeven)



Freya Fusion is trusted by top 20 global pharmaceutical and biotech innovators. With over 200,000 successful eCTD and regulatory submissions delivered, the platform has proven to reduce costs, improve speed, and enhance compliance across regions including the US, EU, Japan, and Health Canada.







#### [8. How does Freya Fusion ensure quality in automated submissions?](#collapseEight)



Freya Fusion features built-in AI-based Quality Control (QC) that validates hyperlinks, bookmarks, XML outputs, and metadata in real time. This ensures 99.8% right-first-time accuracy and near-zero manual rework — drastically improving both submission quality and reviewer confidence.