Medical Writing Medical Documentation Medical Translation

Regulatory-Ready
Medical Content.
Delivered with
Clinical Precision.

Empowering Pharma, Biotech, CROs, and Medical Device organisations with accurate, compliant, multilingual medical content — powered by Human + AI and validated by bilingual doctors and domain experts.

ISO 13485 ISO 17100 ISO 27001 ISO 9001 ISO 18587 HIPAA · GDPR FDA · EMA · CDSCO · PMDA · NMPA
Regulatory Translation Workflow — Live
01
Project Intake & Regulatory ScopeDocument type, authority, language pairs, risk classification
Complete
02
AI Preprocessing & TM AnalysisGlossary match, repetition, MT potential scored
Complete
03
SME & Linguist AssignmentMedical translator + bilingual doctor assigned
Active
04
Human + AI TranslationCAT tool, TM leverage, medical glossary enforcement
Queued
05
Five-Gate QA & SME ReviewISO 13485 / FDA / EMA compliance validation
Queued
06
eCTD / QRD Formatting & Certified DeliveryAuthority-specific format + audit trail
Queued
350+
Languages across all regulatory markets
100,000+
Medical linguists, doctors & specialists
1 Billion+
Words delivered in life sciences globally
30–50%
Faster turnaround vs. traditional LSP
99.5%+
Post-QA accuracy, SME-validated
The Regulatory Risk

When Medical Content Fails,
It's Not a Delay — It's a Risk

Life sciences organisations face a specific, high-stakes documentation challenge that generic translation vendors and unreviewed AI tools cannot address.

Regulatory Exposure
eCTD Submissions Rejected for Terminology Inconsistency
Translation errors between eCTD modules — inconsistent terminology, wrong controlled vocabulary — trigger FDA and EMA queries that delay approvals by months.
Patient Safety
Inaccurate Patient-Facing Content Creates Safety Liability
Mistranslated IFUs, patient leaflets, and consent forms — validated by no medical expert — create patient safety exposure and legal liability in every market.
Trial Delay
Site Activation Delayed by Non-Compliant Document Translation
ICF and protocol translation by non-specialist vendors — not IRB-ready, not back-translation reviewed — delays site activation across multi-country trials.
Operational Risk
Fragmented Vendors — No Consistency Across Markets
Multiple language service vendors produce inconsistent terminology, different formatting, and no cross-market quality governance — creating audit exposure.
AI Risk
Unreviewed AI Translations of Regulated Content
AI-only translation of safety narratives, SmPC sections, and pharmacovigilance documents — without SME validation — generates compliance risk no quality team can afford.
PV Deadline Pressure
PSUR and DSUR Deadlines Missed Due to Translation Bottlenecks
No dedicated PV desk and no 24x7 capability creates submission deadline risk with direct regulatory consequences for your safety programme.
Our Services

End-to-End Medical Content & Localisation

One partner. Every format. Every regulatory authority. Every language your markets require.

🧪
Clinical Trial Documentation
SME-reviewed localisation of all clinical trial documents — from Phase I FIH to Phase III global pivotal. Audit-ready. IRB-compliant. Fast.
ICFProtocolsCRFIBSAE Narratives
📋
Regulatory Submissions
eCTD-formatted, authority-aligned translation for FDA, EMA, CDSCO, PMDA, and NMPA submissions. Bilingual medical experts validate every module.
SmPCPILeCTDRMPNDA/MAA
🩺
Medical Device Content
ISO 13485-certified IFU and device labelling localisation for CE, FDA, EU MDR, and CDSCO device registration. Notified body-ready formatting.
IFUDFULabellingCE/MDRUI Text
💊
Pharmacovigilance
Dedicated PV translation desk with 24x7 availability for EMA and FDA pharmacovigilance deadlines. Accurate, confidential, and always on time.
PSURDSURICSRSafety Updates
✍️
Medical Writing & Content
Original clinical and scientific content by 5,000+ life sciences writers — regulatory dossiers, study reports, patient education, and HCP marketing materials.
CSRProtocolsPatient EdHCP Content
🎓
Multimedia & eLearning
Multilingual eLearning, voiceover, animation, and AR/VR localisation for medical training, HCP education, and product launch content in 50+ languages.
eLearningVoiceoverAnimationAR/VR
Our Delivery Process

Built for Compliance. Designed for Scale.

Eight engineered steps — every one a compliance gate, not just a workflow stage.

1
Project Intake & Regulatory Scope Definition
Document type, target authority, language pairs, risk classification, and submission format defined before any work begins.
2
AI Content Preprocessing & TM Analysis
Medical term extraction, glossary matching, repetition analysis, and MT potential assessment — maximising consistency and speed.
Human + AI model engaged
3
SME & Linguist Assignment
Certified medical translators matched to document type. Bilingual doctors, pharmacists, or clinical researchers assigned as SME reviewers.
SME-in-the-loop activated
4
Human + AI Translation Execution
CAT tool with translation memory and medical glossary enforcement. Humans handle all safety-critical and patient-facing content.
5
Five-Gate QA & Regulatory Validation
AI QA → Linguistic QA → SME Medical Review → Compliance Checklist → Final Approval. Every gate documented for audit trail.
ISO 13485 / FDA / EMA compliance validated
6
DTP, Multimedia & Format Alignment
eCTD formatting, QRD template compliance, IFU layout recreation, voiceover syncing — delivered in your required output format.
7
Certified Delivery via Secure Portal
ISO 27001-compliant, HIPAA/GDPR-aligned secure delivery. Translation certification and change log included on request.
Audit-ready delivery
8
TM & Glossary Update — Continuous Improvement
Approved translations update your translation memory and medical glossary — reducing cost and improving consistency on every subsequent project.

Compliance & Certification Framework

White Globe Quality & Compliance Certifications
All active · Medical & Life Sciences scope
✓
ISO 13485:2016 — Medical Devices Localisation
Active
✓
ISO 17100:2015 — Translation Services Quality
Active
✓
ISO 9001:2015 — Quality Management System
Active
✓
ISO 27001 — Information Security Management
Active
✓
ISO 18587 — MT Post-Editing Standard
Active
✓
HIPAA Compliant Infrastructure
Active
✓
GDPR Compliant Data Processing
Active
✓
FDA · EMA · CDSCO · PMDA · NMPA Aligned
All Markets
Who We Serve

Built for Every Segment of Life Sciences

Each segment has distinct documentation requirements. We serve them all — from Phase I CROs to global Pharma to digital health platforms.

💊
Pharmaceutical & Biotech
FDA · EMA · CDSCO · PMDA
SmPC, PIL, package inserts, drug labelling
eCTD modules, NDA/MAA submission packages
PSUR, DSUR, pharmacovigilance reports
Risk management plans (RMP)
Medical marketing, HCP communications
🔬
Clinical Research (CRO)
Phase I–IV · Multi-Country
Informed consent forms (ICF) — back-translation ready
Clinical protocols and amendments
Case report forms (CRF)
Investigator brochures
Ethics / IRB submission packages
🩺
Medical Devices & Diagnostics
CE · FDA · MDR · ISO 13485
IFU, DFU, quick-start guides
Device labelling and packaging text
CE/MDR Technical Documentation
UI text and software localisation
Maintenance and service manuals
🏥
Hospitals & Healthcare
Patient Safety · Compliance
Patient consent forms and education materials
Discharge instructions and care plans
Telehealth consultation content
Community health campaigns
Medical record and insurance documentation
🧬
Biotech & Life Sciences
R&D · Genomics · Publications
Research publications and white papers
Patent documentation
Grant proposals and investor materials
Genomic counselling content
Clinical-genomic technical reports
📱
HealthTech & Digital Health
GDPR · HIPAA · App Compliance
App UI and UX localisation
Privacy notices and data consent (GDPR/HIPAA)
Wearable device documentation
Remote monitoring patient content
Digital health education modules
Programme Evidence

Delivered at Regulatory Scale

Client names are confidential. Regulatory outcomes are not.

Global Pharma · Regulatory Affairs · EU Markets
MAA Submission Package — 15 EU Languages, EMA Deadline
A global pharmaceutical company required simultaneous SmPC, PIL, and RMP translation into 15 EU languages for an MAA submission — strict EMA deadline, QRD template compliance mandatory, bilingual pharmacist SME review required for all patient-facing sections.
Approach: Parallel translation across 15 languages by certified medical linguists, QRD formatting, bilingual pharmacist review of all patient-facing sections.
15
EU languages, parallel delivery
Zero
QRD compliance queries raised by EMA
On Time
MAA submission filed on schedule
Global CRO · Clinical Operations · 12 Countries
Phase III Oncology Trial — ICF & Protocol in 12 Languages
A global CRO managing a Phase III oncology trial required ICF and protocol localisation across 12 countries — IRB-ready formatting, SME back-translation review, strict site activation timeline with no room for documentation delay.
Approach: Dedicated clinical trial team, SME back-translation for all ICFs, IRB-compliant formatting per country, 24x7 PM support throughout.
12
countries, IRB-ready delivery
40%
faster than previous vendor
Zero
site activation delays caused by documentation
Medical Device Manufacturer · EU MDR / CE Compliance
IFU Localisation for MDR Transition — 22 EU Languages
A global medical device manufacturer facing EU MDR compliance deadline required IFU and labelling localisation across all 22 EU official languages — ISO 13485-certified workflow, notified body-ready formatting, compressed timeline for market continuity.
Approach: ISO 13485 certified workflow, parallel translation with device SME review, EU MDR-compliant formatting, change control documentation included.
22
EU official languages, MDR-compliant
Zero
notified body queries on linguistic review
Market
continuity maintained — no product withdrawal
Why White Globe

The Capability Comparison That Matters

In regulated life sciences content, capability differences translate directly into compliance risk — not just quality preference.

Capability White Globe Traditional LSP AI-Only Tool
SME Medical Reviewer (doctor / pharmacist)✓ Every regulated document✗ Rarely available✗ Never
ISO 13485:2016 & ISO 17100 Certification✓ Both active? Varies by provider✗ Not applicable
Human + AI hybrid model (structured)✓ Engineered integration✗ AI add-on only✓ AI only — no human gate
eCTD / QRD authority formatting✓ Full formatting service? Basic DTP only✗ No capability
Pharmacovigilance — 24x7 PV desk✓ Dedicated PV team✗ Standard hours only✗ No capability
Multimedia + eLearning localisation✓ Full in-house service✗ Usually outsourced✗ No capability
HIPAA + GDPR + ISO 27001 compliance✓ All three active? Partial / variable✗ Data risk exposure
Back-translation — standard for regulated content✓ Part of SME review protocol? On request only✗ Not possible
350+ languages — all major regulatory markets✓ Full global coverage? Limited pair coverage? Quality varies widely

Your Regulatory Submission
Cannot Wait.
Neither Can We.

Whether you are preparing a regulatory submission, managing a global clinical trial, or navigating MDR compliance — the right conversation starts with an honest assessment of your documentation requirements. Response within 48 hours.

📋
Request a Compliance Review Regulatory translation specialists review your context within 48 hours. No obligation.
→
📄
Request an Anonymised Sample See exactly how an eCTD module or IFU localisation is structured and delivered.
→
🚀
Start with a Pilot Translation One document type, your regulatory context, our SME team. Validate before committing.
→
💬
Speak to a Medical Translation Specialist No sales pitch. A working conversation about your regulatory documentation challenge.
→
Request a Compliance Review
Tell us about your regulatory documentation requirements. One of our medical translation specialists will respond within 48 hours.
🔒 ISO 27001 · HIPAA · GDPR compliant · Enterprise NDA available on request