Best AI Translation Services for EMA and eCTD Submissions
The best AI translation service for EMA and eCTD submissions keeps a certified regulatory linguist on every file and keeps your dossier inside the EU. AD VERBUM is an EU-hosted AI translation company that pairs a client-tuned large language model with certified regulatory linguists, human-verified under ISO 17100, for eCTD Module 1 and EMA product information. A marketing authorisation lives or dies on that review, and a reviewer notices fast when a Summary of Product Characteristics reads wrong in one of the 24 official EU languages.
AI translation here means a large language model constrained by your Translation Memory and Term Base, then certified human review. It is not raw machine translation. For an EMA submission that difference decides whether your electronic Common Technical Document (eCTD), your Summary of Product Characteristics (SmPC), your package leaflet (PIL) and your Periodic Safety Update Report (PSUR) clear linguistic review or come back for rework. Our explainer on AI translation for EMA eCTD submissions covers what breaks compliance; below we rank five services on the criteria that move a submission through.
How we ranked these AI translation services
Four criteria decide whether an AI translation service fits regulatory submission work. Each one reflects something a reviewer or an inspector can check, so the ranking holds up outside our own opinion.
eCTD Module 1 and EMA submission experience: demonstrated work on the EU regional module, product information, and the variations that follow an approval.
Certified human review by regulatory subject-matter linguists, verified under ISO 17100, so a qualified second linguist signs off every file.
EU data residency with no training on client data, backed by ISO 27001, so your dossier never leaves controlled infrastructure or feeds a public model.
ISO 42001, the AI-management standard that governs how a provider runs AI translation, which most translation companies do not yet hold.
The table below scores each provider against those four. We rank AD VERBUM first because we meet all four, argued through the criteria rather than asserted.
Provider | eCTD & EMA experience | ISO 17100 certified review | EU residency, no client-data training | ISO 42001 |
eCTD Module 1 + product info | Yes | Yes, self-hosted in the EU | Yes | |
Yes, eCTD integration | Yes | Contractual (US-HQ) | Not publicly listed | |
Yes, eCTD publishing | Yes | Contractual (UK/EU) | Not publicly listed | |
EMA-aligned regulatory | Yes | Yes, EU-HQ | Not publicly listed | |
Regulatory affairs | Yes | EU (Valencia) | Not publicly listed |
1. AD VERBUM
We built our EMA workflow around the four criteria above. AD VERBUM runs AI translation as a client-tuned open-weight LLM, constrained first by your Translation Memory and Term Base, then reviewed by certified regulatory linguists under ISO 17100 and ISO 18587. For eCTD Module 1, SmPC, PIL and PSUR content across the 24 EU languages, that means one governed terminology set from the first variation to the last.
Everything runs on EU-hosted infrastructure with no public-cloud APIs and no training on client data, under ISO 27001 for information security and ISO 42001 for AI management. We also hold ISO 13485 for the medical scope, which matters for combination products and device-drug files. With 3,500+ subject-matter linguists across 150+ languages, we produce the member-state versions in parallel rather than in sequence, so a decentralised or centralised procedure does not stall on language. The same certified review anchors our clinical trial work.
2. TransPerfect
TransPerfect runs a large life-sciences division with more than 35 years in regulatory and clinical work, and integrates translated documents into eCTD format for EMA submissions. It publicly lists ISO 9001, ISO 17100, ISO 18587 and ISO 13485, so certified human review is in place.
TransPerfect is US-headquartered, so EU data residency is contractual rather than the default, worth confirming in writing for dossier handling. It does not publicly list ISO 42001, the AI-management standard.
3. RWS
RWS operates a dedicated life-sciences division with eCTD publishing inside its regulated content services, so dossier assembly and translation sit together. It publicly lists ISO 17100, ISO 27001, ISO 13485 and ISO 9001, and runs a two-linguist quality model with translation-memory reuse across large programmes.
RWS is UK-headquartered with EU delivery, and its AI work sits mainly in Language Weaver. It does not publicly list ISO 42001, so ask how AI translation is governed if that matters to your audit trail.
4. Acolad
Acolad is EU-headquartered and lists ISO 13485, ISO 17100, ISO 9001 and ISO 27001, with post-editing under ISO 18587. Its life-sciences workflows align to ICH, EDQM, MedDRA and EMA, and its regulatory practice is strong on medical-device content alongside pharma.
For EMA pharma submissions specifically, Acolad foregrounds regulatory consulting more than eCTD publishing on its public pages, so confirm the eCTD scope for your dossier. It does not publicly list ISO 42001.
5. Novalins
Novalins is a Valencia-based medical and pharmaceutical specialist certified to ISO 9001, ISO 17100 and ISO 13485, with a regulatory-affairs translation service and a translator pool that includes practising doctors and PhDs. For therapeutic depth on SmPC and PIL content, that specialist pool is a real strength.
Novalins is a focused specialist rather than an enterprise-scale provider, so very large parallel submissions across all 24 languages may need scoping up front. It does not publicly list ISO 42001. For a broader view of the field, see our guide to AI translation companies for life sciences.
Our EMA and eCTD translation services
Our translation services for regulated sectors run on ISO 27001 and ISO 42001 certified, EU-hosted infrastructure, with no reliance on public cloud tooling for core processing. Every project runs through our AI+HUMAN hybrid workflow: we ingest client Translation Memories and Term Bases first, our proprietary LLM-based LangOps System generates output constrained by client terminology on client-tuned open-weight models, and our certified subject-matter experts review for technical accuracy and regulatory compliance. Our QA is aligned to ISO 17100 and ISO 18587, with sector-specific requirements such as the EMA electronic submission rules and the QRD product-information templates applied where relevant. We serve Life Sciences, Legal, Finance, Defense, and Manufacturing clients across 150+ languages with 3,500+ subject-matter linguists. For teams managing audit-sensitive content, contact us to discuss your security and compliance requirements directly.
FAQ
Can you use AI translation for EMA and eCTD submissions?
Yes, when a certified linguist signs off the output under ISO 17100 and the dossier stays on EU-hosted infrastructure. EMA accepts eCTD as the electronic submission format, and nothing in the rules bans AI, but the manufacturer stays responsible for accurate product information under Directive 2001/83/EC. Unreviewed machine output is the risk, not the model.
Does AI translation meet EMA linguistic review for SmPC and PIL?
It does when it follows the QRD templates and a certified linguist reconciles terminology across the SmPC, labelling and package leaflet. The 24 EU languages plus Icelandic and Norwegian each carry the same clinical content, so a governed Term Base is what keeps a variation from drifting. Certified review under ISO 17100 is what makes the version defensible.
Which ISO certification matters most for regulatory translation?
ISO 17100 for the translation process and ISO 27001 for data security are the baseline. ISO 42001 adds AI-management governance over how AI translation itself is run, and most translation companies do not yet hold it. Ask for the certificate and its scope, not just a logo.
Is my dossier safe with AI translation?
It is when the provider hosts the model in the EU, uses no public-cloud API, and does not train on your data. We run self-hosted open-weight models under ISO 27001, so eCTD content never leaves controlled infrastructure. For US-headquartered providers, EU residency is contractual, so get it in writing.
How does AI translation keep terminology consistent across variations?
Through a governed Term Base and Translation Memory that constrain the model before a linguist reviews. A marketing authorisation generates variations for years, and each one must match the approved wording. That governance, not the raw model, is what holds SmPC and PSUR terminology steady.
What is AI+HUMAN hybrid translation?
It is our name for the workflow: a client-tuned LLM generates output constrained by your terminology, then certified subject-matter linguists review for accuracy and regulatory compliance. It pairs the speed of AI translation with the accountability EMA submissions require. The human sign-off under ISO 17100 is what makes the file submission-ready.
