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2 min read
The Challenge: Increasing Pressure, Shrinking Deadlines
For global life sciences organizations, the path to regulatory approval is more complex and time-sensitive than ever. Whether it’s an NDA, BLA, or lifecycle submission, every delay can mean lost revenue, prolonged patient wait times, and higher operational costs.
But behind these delays lies a common set of pain points:
- Fragmented publishing processes spread across regions and teams
- Manual document handling and time-consuming QC reviews
- Repetitive data entry between systems and submission formats
- High dependency on human resources during peak submission cycles
- Compliance risks due to inconsistent formatting or validation errors
As regulatory teams juggle growing submission volumes, they need more than manpower—they need intelligent automation that scales, standardizes, and accelerates submission readiness.
The Solution: Freyr’s AI-First Approach to Regulatory Submissions
Freyr has reimagined global regulatory operations with Freya.Fusion—an AI-powered, automation-first submission platform designed to cut submission timelines by up to 60% while maintaining industry-leading accuracy.
Freya.Fusion transforms the end-to-end publishing and submission process into a connected, data-driven ecosystem. From planning to delivery, it automates redundant activities, standardizes submission formats, and provides real-time visibility across global teams.
With modules like:
- freya.Submit – Automates eCTD, NeeS, and SPL publishing and validation
- freya.Content – Enables structured content reuse and version control
- freya.DossierBuilder – Streamlines dossier compilation and QC tracking
- freya.RIM & RTQ – Simplifies regulatory information management and query response tracking
Freyr gives regulatory teams a single intelligent platform that integrates seamlessly with existing DMS and HA templates (FDA, EMA, Health Canada, PMDA, TGA, GCC, and more).
How Freya.Fusion Delivers 60% Faster Submissions
Here’s how Freyr helps clients overcome the core bottlenecks that slow down FDA submissions:
Pain Point | Freyr’s Solution | Impact |
| Manual Publishing Workflows | Automation of Document & Submission-Level Publishing (DLP & SLP) | 43% reduction in manual effort |
Time- Consuming QC Checks |
AI-powered QC validation (bookmarks, hyperlinks, metadata) |
25% reduction in QC efforts |
| Fragmented Global Teams | 24/5 publishing coverage from global hubs (India, US, Colombia, EU) | Round-the-clock support |
| Urgent FDA Filings | Dedicated “Red Alert” team with 2-hour acknowledgment and 24-hour turnaround | Faster market readiness |
| Lack of Process Visibility | Centralized dashboards and real-time submission tracking |
Improved governance & accountability |
These efficiencies have allowed Freyr’s clients to transform submission outcomes:
- 60% reduction in overall publishing time
- 99.8% first-time-right submissions
- 99.99% on-time delivery
- 30% lower submission management costs
Proven Results: From Bottlenecks to Breakthroughs
Freyr’s Publishing Center of Excellence (CoE) supports over 200 clients globally, including 8 of the top 10 pharmaceutical and biotech companies. With 400+ publishing experts, 200,000+ submissions, and 24/5 coverage, Freyr has become a trusted partner for regulatory acceleration.
In one engagement, a global innovator reduced NDA submission timelines from 90 days to just 30 days using Freya.Fusion’s automated submission framework—while improving quality to near-perfect levels.
Beyond FDA: Global Readiness Across Markets
Freya.Fusion is built to handle the complexity of multi-regional submissions. Whether you’re filing to the FDA, EMA, Health Canada, PMDA, or TGA, the platform supports country-specific DTD and XSD templates and integrates validation workflows to ensure “right-first-time” submissions across markets.
Combined with Freyr’s hybrid delivery model (onsite, nearshore, offshore), clients gain flexibility, cost efficiency, and time-zone coverage—ensuring business continuity even during high-volume submission cycles.
Why Partner with Freyr
Choosing Freyr means choosing a partner that combines regulatory depth, technology innovation, and operational excellence.
Here’s why top life sciences companies trust Freyr:
- AI-driven publishing automation that eliminates manual inefficiencies
- Proven 99.99% on-time delivery across 200,000+ submissions
- Global scalability with teams across 20+ hubs
- Dedicated urgent submission teams for 24-hour turnaround
- ISO 9001 & 27001 certified quality frameworks ensuring compliance integrity
Accelerate Compliance. Reduce Timelines. Empower Innovation.
In a world where regulatory speed defines market success, Freyr empowers companies to stay ahead. Freya.Fusion not only accelerates submission timelines but also liberates your teams to focus on strategic science—rather than repetitive tasks.
Let’s make “faster, smarter, compliant submissions” your new normal.
