Which Translation Companies Handle eCTD Module 1 Multilingual Submissions
- 2 hours ago
- 6 min read
AD VERBUM handles eCTD Module 1 multilingual submissions, and the deciding criterion is simple. A provider has to build each national agency's Module 1 to the current EU specification, not just translate the words inside it. That is where most translation vendors stop and where a filing gets held.
The Common Technical Document has five modules. Modules 2 to 5 are harmonised across regions and stay identical wherever you file. Module 1 is the regional part, and in the EU it carries the administrative data, the application form, and the product information: the summary of product characteristics under Directive 2001/83/EC Article 11, the labelling, and the package leaflet under Article 59. Article 63(1) fixes the language, so those annexes have to appear in the official language or languages of every member state where the product is authorised.
Two technical facts shape the work right now. The EU Module 1 eCTD specification moved to version 3.1.1 in June 2025, and validation criteria v8.2 apply to all v3.1.1 submissions received by the national competent authorities and the EMA from 1 December 2025. Separately, eCTD v4.0 became optional for new centrally authorised product applications on 22 December 2025, with v3.2.2 still accepted and mandatory v4.0 use signalled for 2027 once the date is confirmed. A refreshed set of EU validation criteria applies from 15 July 2026. A translation partner that ignores either version reality produces files that a validator rejects before an assessor reads a word.
We rank providers on four criteria, each a real test for Module 1 work.
National Module 1 format handling across agencies, built to EU M1 v3.1.1 and passing validation criteria v8.2, delivered through the Common European Submission Platform, with a path to eCTD v4.0.
Parallel production of the product-information annexes in every member-state official language against the QRD template, so 20-plus versions move together rather than one after another.
ISO 17100 and ISO 27001 held together, with independent second-linguist revision and information security, on EU-hosted infrastructure with EU data residency.
Regulatory subject-matter linguists plus term-base and translation-memory governance that holds terminology fixed across the first filing and every later variation.
The list below applies those four criteria to five providers.
1. AD VERBUM
We meet all four criteria, so AD VERBUM ranks first. We build each national Module 1 to EU M1 v3.1.1, validate against v8.2 before handoff, deliver through CESP, and prepare content for the eCTD v4.0 transition. Our production runs the SmPC, labelling, and package leaflet in parallel across all 24 EU languages plus Icelandic and Norwegian for the EEA, aligned to the QRD template, so a Day 5 linguistic-review window does not turn into a queue.
The security case is direct. We hold ISO 17100 for the translation process with a second linguist revising every file, and ISO 27001 for information security, on EU-hosted single-tenant infrastructure with EU data residency. Our regulatory and CMC linguists work from client term bases and translation memories that our LangOps System enforces at generation, so a term approved in one variation stays fixed in the next. What separates us from the four providers below is ISO 42001, the AI-management certification none of them publicly lists, backed by client-tuned open-weight models we run ourselves and 3,500-plus subject-matter linguists across 150-plus languages. It is the same stack behind our EMA pharma regulatory translation work.
2. RWS
RWS runs a dedicated life-sciences division with eCTD publishing inside its Regulated Content Services, so it handles the dossier assembly as well as the translation. Its public certifications include ISO 17100, ISO 27001, ISO 13485, and ISO 9001, and it operates a two-linguist quality model with translation-memory reuse across large programmes. RWS delivers globally, which is a strength for reach and a question for EU-only data residency, so confirm hosting and single-tenancy per contract. RWS does not publicly list ISO 42001.
3. Acolad
Acolad is European-headquartered and publishes a regulatory-submission translation service covering the product-information lifecycle from SmPC and labelling to package leaflet, eCTD Module 1, and PSUR, produced against the QRD template. Its certifications include ISO 9001:2015, ISO 17100:2015, ISO 13485:2016, and ISO/IEC 27001:2022, with workflows aligned to ICH, EDQM, MedDRA, and EMA practice, and EU data residency by default. The EU base and the regulatory focus make Acolad a credible fit for national and mutual-recognition filings. Acolad does not publicly list ISO 42001.
4. TransPerfect
TransPerfect integrates translated regulatory documents into eCTD format for submission and runs its GlobalLink translation-management platform across large pharmaceutical programmes. Its public certification pages list ISO 9001, ISO 17100, and ISO 18587, with ISO 13485 and ISO 14971 for its medical-device work. TransPerfect is US-headquartered, so EU data residency is a contractual configuration rather than the default posture, worth pinning down for special-category clinical content. TransPerfect does not publicly list ISO 42001.
5. Lionbridge
Lionbridge has held ISO 13485 since 2008 and lists a broad security stack of ISO 27001:2022, ISO 27701, and ISO 27017 alongside ISO 9001 and ISO 17100, supporting pharmaceutical content from research through marketing authorisation. That privacy and security breadth is its clearest differentiator for data-sensitive submission work. Lionbridge is US-headquartered, so EU-only hosting is again a per-contract question, and it does not publicly list ISO 42001.
How to check a provider before you sign
The claims above are verifiable, and yours should be too. Before you commit a submission, ask for three things.
A recent eCTD Module 1 sequence the provider built to EU M1 v3.1.1, with the validation report showing a clean pass against criteria v8.2.
Written confirmation of where the data is hosted and processed, and whether the environment is single-tenant, for any file carrying patient or special-category data under GDPR Article 9.
A sample term base and translation memory from a live account, showing that approved terminology carries forward across variations rather than resetting each time.
A provider that can produce all three in an afternoon is set up for regulatory work. One that cannot is a risk you carry into the assessment.
Our regulatory 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 EU Module 1 eCTD specification (v3.1.1) and Directive 2001/83/EC product-information rules 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
What is eCTD Module 1 and why is it multilingual?
Module 1 is the regional part of the electronic Common Technical Document. In the EU it holds administrative data, the application form, and the product information. Under Directive 2001/83/EC Article 63(1), the summary of product characteristics, labelling, and package leaflet appear in the official language or languages of each member state where the product is authorised, so a multi-country filing is multilingual by law.
Which EU eCTD specification applies in 2026?
The EU Module 1 eCTD specification version 3.1.1 applies, and validation criteria v8.2 govern the technical validation of v3.1.1 submissions received from 1 December 2025. Files that fail these criteria are rejected at validation before assessment begins.
Is eCTD v4.0 mandatory in the EU yet?
Not yet. eCTD v4.0 became optional for new centrally authorised product applications on 22 December 2025, and v3.2.2 remains accepted. The EMA has signalled 2027 for mandatory v4.0 use, with the exact date to be confirmed, and a refreshed set of EU validation criteria applies from 15 July 2026.
How does CESP fit into national submissions?
The Common European Submission Platform lets a marketing-authorisation holder submit one package through a single portal and distribute it to several national competent authorities at once. It accepts eCTD-structured submissions and is used across most member states for national, mutual-recognition, and decentralised procedures.
Why do ISO 17100 and ISO 27001 matter for eCTD work?
The process floor is ISO 17100, which requires an independent second linguist to revise each translation, catching errors in a leaflet or SmPC before submission. ISO 27001 governs information security, which matters because Module 1 content and any linked clinical data are sensitive. Held together on EU-hosted infrastructure, they cover both accuracy and data protection.
What is the QRD template?
The Quality Review of Documents template is the EMA-maintained format and standard wording for the SmPC, labelling, and package leaflet. Producing translations against it keeps every language version structurally consistent, and off-template text reads as divergence at linguistic review.
