Your 2026–2029 compliance runway is shorter than it looks. eCTD v4.0, regional nuance, and nonstop label changes are converging — fast. Run the entire regulatory lifecycle in one connected system. Keep reading to see how to turn fragmented work into a single, audit-ready flow (and make “first-time-right” your default instead of your hope).
Who should read & why keep going: If you lead Regulatory Affairs, Submissions, or Labeling, this post gives you a concrete blueprint to cut rework, compress cycles, and de-risk audits.
The Compliance Speed-run — what we cover in this blog:
- Why global compliance needs a rethink
- The FDA, EMA, PMDA landscape: what’s changing and why it matters
- What is freya fusion?
- How freya fusion enables global compliance
- Where freya fusion fits in the FDA–EMA–PMDA journey
- Why a unified, AI-First Regulatory Information Management System (RIMS) matters now
- Practical takeaways for regulatory teams
(Think of it as a regulatory puzzle that always fits.)
Why global compliance needs a rethink
Regulatory teams face accelerating complexity — constant updates from FDA, EMA, and PMDA, shifting eCTD v4.0 timelines, and divergent standards that strain people and processes across markets. FDA now accepts eCTD v4.0 (since Sept 16, 2024), the EU targets mandatory v4.0 for CAPs in 2026, Japan plans v4-only from April 2026, and all ongoing EU trials had to be in CTIS by Jan 31, 2025. The result is avoidable delays, fragmented data, and compliance risk at scale, especially when submissions, labeling, and intelligence live in silos. Now imagine an AI-First RIMS orchestrating registrations, submissions, labeling, documents, and real-time intelligence — end to end, in one cloud.
Not a vision: it’s here now, accelerating speed, integrity, and oversight! You will know more as you read ahead!
The FDA, EMA, PMDA landscape: what’s changing and why it matters
Agencies are progressing toward eCTD v4.0. And at the same time, variations such as FDA’s allowance for certain “grouped submissions,” EMA’s “work‑sharing,” and PMDA’s pathways for simultaneous related filings create regional nuances that demand configurable processes and proactive intelligence. Teams that harmonize processes across these differences gain faster reviews, fewer deficiencies, and better predictability across portfolios.
What is freya fusion?
freya fusion is the next‑generation, AI‑First, GxP‑compliant regulatory cloud built by regulatory and technology experts to manage the entire lifecycle — from global product registration to eCTD v4.0 submissions, labeling operations, and regulatory intelligence. It consolidates core capabilities such as automated submission publishing, structured content authoring, centralized document management, and conversational access via freya, an AI-First regulatory chatbot, to reduce manual effort and improve first‑time‑right outcomes.
Built for regulatory by Freyr — an integrated regulatory solutions provider — freya fusion is the only platform born inside an integrated solutions provider and delivered through a strategic partnership. It’s rooted in 15 years of deep domain expertise, powered by advanced AI/ML and integrated data intelligence, and safeguarded by human-in-the-loop verification.
How freya fusion enables global compliance
Unified backbone for regulatory operations
- Single cloud platform for registrations, submissions, labeling, documents, and intelligence—eliminating hand‑offs across tools and anchored to a governed single source of regulatory data. No duplicate repositories or re-keying; changes propagate everywhere with lineage and version control.
- AI‑first automation and validation to cut errors, accelerate readiness, and maintain inspection‑ready audit trails.
Built‑in regulatory intelligence
- Real‑time monitoring and search across intelligence of 100k regulations from 1500+ global regulatory authorities to surface the latest guidance and policies for FDA, EMA, PMDA, and beyond, with human in the loop verification system.
- Conversational access via freya, an intelligent chatbot for fast, source‑backed answers drawn from system‑of‑record data and curated intelligence.
Structured content and dossier assembly
- Component‑based automated content authoring and reuse to generate region‑specific dossiers and SPL/label content without reinventing the wheel.
- End‑to‑end eCTD support with eCTD v4.0‑aligned validation (wherever applicable) and integrated viewing to streamline compilation and lifecycle management.
Feature deep‑dive: Modules aligned to FDA, EMA, PMDA needs
freya.submit — accelerated submissions with AI
- Plan, compile, validate, publish, and track global submissions in a single, cloud‑native workspace with support for eCTD v3.2.2 and v4.0 where applicable; along with alternative submission formats like NeeS.
- Regional validation rules and auto‑checks tuned for FDA, EMA, and PMDA help reduce errors and speed approvals across markets.
freya.docs — purpose‑built regulatory DMS
- 21 CFR Part 11 and GxP‑compliant document control with secure signatures, audit trails, and metadata‑driven search to remain inspection‑ready.
- Seamless export to publishing tools with controlled templates and versioning to support global filings without content drift.
freya.content — component‑based content at scale
- Author once, reuse everywhere: create modular content blocks for CTD/eCTD, SPL, IFUs, and labels, with automated change propagation.
- Structured authoring and interoperable pipelines into freya.submit for consistent, submission‑ready outputs across regions.
freya.label — compliant labeling and packaging
- Global‑to‑local cascade of CCDS changes with impact assessment, version control, and real‑time validation across 120+ countries.
- Cross‑functional collaboration, template‑ready assets, and audit‑ready trails to prevent recalls and accelerate market releases.
freya.automate — regulatory workflow automation
- Agentic automations for hyperlinking, bookmarks, validation, translation, and label comparisons to remove repetitive work from publishing.
- SME‑guided workflows and knowledge‑aware outputs aligned to regulatory conventions and internal standards.
freya.rtq and freya chatbot — query intelligence and instant answers
- Centralized RTQ repository and smart drafting to respond faster and more consistently to FDA/EMA/PMDA queries using precedent and context.
- freya chatbot surfaces precise, explainable answers from product data, submission history, and regulatory intelligence to speed decisions.
Where freya fusion fits in the FDA–EMA–PMDA journey
| Regulatory step | FDA | EMA | PMDA | How freya fusion helps |
|---|---|---|---|---|
| Format and validation | 510(k)/PMA/IND/NDA eCTD rules and checks | Centralized/variations and work‑sharing | eCTD v4.0 readiness and lifecycle | freya.submit applies regional validation, auto‑checks, and eCTD v4.0 support to reduce errors and rework. |
| Grouped/variation strategy | Grouped supplements for identical CMC changes | Work‑sharing for grouped variations | Simultaneous related filings pathways | Regulatory intelligence and planning in freya fusion help select optimal strategy per agency and manage risk. |
| Labeling | HA‑aligned labels and packaging | MDR‑aligned device labeling | PMDA‑specific labeling norms | freya.label enforces templates, version control, and real‑time validation across markets. |
| Query management | FDA IR, DR, CR cycles | EMA LoQ and clock‑stops | PMDA inquiries and consultations | freya.rtq and freya chatbot enable precedent search, draft support, and conversational access to evidence. |
Table: Why a unified, AI‑first RIMS matters now
| Challenge | Impact | freya fusion approach |
|---|---|---|
| Siloed tools for docs, submissions, labeling | Duplicates work, increases errors | One cloud platform with structured content and integrated publishing. |
| Reactive monitoring of agency updates | Missed changes and avoidable rework | Real‑time regulatory intelligence with conversational access to insights. |
| Manual validation and QC | Longer timelines, query risk | Automated checks, eCTD v4.0‑aligned validation, and guided workflows. |
| Inconsistent query responses | Delays, credibility risk | RTQ repository, precedent linking, and smart draft builders. |
Practical takeaways for regulatory teams
- Stand up a single source of truth for data: centralize regulated content, registrations, and submission status to improve oversight and reduce cycle time.
- Prepare for eCTD v4.0: align validation, metadata, and lifecycle tracking now to avoid crunch as PMDA mandates arrive and FDA/EMA deadlines approach.
- Operationalize grouped/variation strategies: use intelligence and planning to select FDA grouped supplements, EMA work‑sharing, or PMDA simultaneous filings.
- Automate the tedious 80%: apply freya.automate for hyperlinking, bookmarks, validation, and translations to accelerate publishing and reduce errors.
- Industrialize labeling and artwork: enforce templates, version control, and cross‑market consistency using freya.label and freya.artwork.
- Institutionalize query knowledge: build a living RTQ memory and enable conversational retrieval via freya chatbot to speed health authority responses.
Final thoughts: compliance without chaos
Global compliance is no longer about stitching together point tools; it’s about orchestrating submissions, labeling, content, and intelligence with a unified, AI‑First backbone. freya fusion gives regulatory affairs professionals, submission managers, and decision‑makers the operational confidence to meet FDA, EMA, and PMDA expectations while improving speed, data integrity, and audit‑readiness across portfolios. Explore the platform overview to see how a composable, connected, and cognitive approach becomes a daily advantage for global teams.
Explore freya fusion:
Next step: review use‑case fit, see a guided demo, and assess acceleration opportunities across submissions, labeling, and regulatory intelligence.
Book a fast fit-check, bring your toughest label or submission scenario, and we’ll walk how it’d flow in freya fusion—no slides, just system.