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2 min read
In an era of ever-evolving regulatory requirements and shrinking submission timelines, publishing teams across the life sciences industry face an uphill battle. Managing thousands of global submissions, ensuring “right-first-time” accuracy, and adapting to frequent format changes — all while meeting Health Authority (HA) expectations — is no small feat.
Freyr understands these challenges deeply. With 200,000+ global submissions, 99.99% on-time delivery, and >98% right-first-time accuracy, Freyr has emerged as the trusted strategic partner to the world’s top pharmaceutical, biotech, and consumer health companies.
Let’s explore the key problem areas and how Freyr’s Publishing & Submissions Center of Excellence (CoE) turns them into opportunities for efficiency and quality.
1. The Bottleneck of Manual Publishing
The Challenge:
Manual publishing and QC processes often lead to delayed timelines and rework. Teams spend hours hyperlinking, validating, and formatting, leaving little time for value-added work.
Freyr’s Solution:
Freyr’s proprietary tool Freya. Fusion™ AI Regulatory Platform automate document compilation, QC, validation, and submission management across eCTD, NeeS, and paper formats. Automation-driven workflows reduce publishing efforts by 43% and QC efforts by 25%, improving productivity by 60% while maintaining 99.8% quality adherence.
2. Quality Control Inconsistencies
The Challenge:
Multiple handoffs and manual validation increase the risk of technical errors — a common cause of HA rejections.
Freyr’s Solution:
Freyr’s checklist-driven QC framework ensures consistency at both Document Level Publishing (DLP) and Submission Level Publishing (SLP). With zero-defect outputs and stringent SOPs, Freyr ensures that every submission meets both global and regional technical standards — from FDA and EMA to Health Canada, SFDA, and EAEU.
3. Limited Scalability During Peak Loads
The Challenge:
Regulatory workloads fluctuate dramatically. Many teams struggle to meet deadlines when urgent or simultaneous global submissions arise.
Freyr’s Solution:
Freyr operates with a dedicated global publishing workforce of 400+ experts, supported by a 15% rolling bench to rapidly scale up during surge periods. A 24/5, three-shift “Red Alert Team” model ensures round-the-clock urgent submission coverage, completing critical filings in under 24 hours with no added cost for <12% of monthly urgent volume.
4. Siloed Systems and Fragmented Data
The Challenge:
Disconnected authoring, tracking, and validation systems slow down publishing and create versioning issues.
Freyr’s Solution:
The Freya.Fusion Unified Regulatory Platform brings together RIM, Dossier Management, Labeling, and Submissions into a single ecosystem. Its modular suite — including Freya. Submit, Freya.Docs, Freya.DossierBuilder, and Freya.Archive — delivers real-time dashboards, automated templates, and seamless DMS integration.
The result? End-to-end visibility, traceability, and faster turnaround across submission lifecycles.
5. Managing Global Regulatory Variations
The Challenge:
Each market follows distinct submission standards — US eCTD 3.2 and 4.0, EU MAA formats, China eCTD, Japan PMDA eCTD v4.0 — making compliance complex.
Freyr’s Solution:
Freyr supports all major Health Authority formats (FDA, EMA, Health Canada, PMDA, SwissMedic, TGA, SFDA, EAEU, and more). With 20+ global delivery hubs and experience in 120+ countries, Freyr ensures every submission is region-specific, compliant, and delivered on time.
6. Cost and Resource Optimization
The Challenge:
Maintaining internal publishing infrastructure and expertise is costly, especially when demand fluctuates.
Freyr’s Solution:
Through hybrid delivery models (onsite–nearshore–offshore) and Digital BPO frameworks, Freyr enables cost reductions of up to 50% without compromising quality or compliance.
Freyr’s publishing engagements with global pharma leaders have achieved 30–50% cost savings and >98% right-first-time metrics across multi-year collaborations.
Why Global Leaders Choose Freyr
- 400+ publishing experts with 5–15 years of experience
- 99.99% on-time delivery and zero rework culture
- 200,000+ global submissions handled
- Continuous innovation through automation and AI
- Global coverage: 24/5 support across US, EU, India, Canada, and LATAM and all major markets
- Long-term partnerships with 160+ clients (10+ years)
The Future of Regulatory Publishing is Digital — and Freyr is Leading It
With a strong blend of human expertise, digital innovation, and automation excellence, Freyr transforms complex regulatory publishing into a smooth, intelligent, and compliant process.
For organizations aiming to achieve faster approvals, error-free submissions, and significant operational savings, partnering with Freyr means future-proofing your regulatory operations.
Get your next submission approved — faster, smarter, and error-free. Connect with Freyr’s Publishing Experts Now.
