Specialist service
Regulatory Submission Translation Services
Accurate, compliant translation of CTD/eCTD dossiers and regulatory documentation for marketing authorisation applications across every market you file in.
What Is Regulatory Submission Translation?
Regulatory submission translation is the accurate translation of the documentation pharmaceutical and life sciences companies submit to health authorities — such as the MHRA, EMA, FDA and other national regulators — to gain marketing authorisation for a drug or medical product. This includes the Common Technical Document (CTD) and its electronic counterpart, the eCTD, which together compile a product’s quality, safety and efficacy data into the standardised five-module format regulators require.
Because these documents underpin the legal approval of a product to reach patients, even small translation or formatting errors can delay a filing, trigger regulatory queries, or in the worst case, block market entry altogether. At TranslationsInLondon, every regulatory submission translation is produced by qualified human linguists with regulatory affairs experience, following an ISO 17100-aligned translation, editing and proofreading (TEP) process. We do not use machine translation for regulatory submission content.
Our team has hands-on experience preparing and reviewing QRD (Quality Review of Documents) pharmaceutical content for major life sciences language service providers, so we know what national regulators expect a translated SmPC or PIL to look like before it reaches them.
Regulatory Documents We Translate
Document Type
Examples
CTD/eCTD Modules
Module 1 (regional administrative information), Module 2 (summaries), Module 3 (quality/CMC), Module 4 (nonclinical study reports), Module 5 (clinical study reports)
Product Information
Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs), QRD-template-compliant labelling text
Marketing Authorisation Applications
MAA/NDA dossiers, variations and renewals
Regulatory Correspondence
Health authority queries and responses, expert reports
Quality & Manufacturing
Chemistry, Manufacturing and Controls (CMC) documentation, validation protocols, SOPs
Our Regulatory Submission Translation Process
- Scoping & Terminology Setup — We review source documents, confirm target languages/markets, and build or apply a product-specific glossary and style guide to ensure consistency across every module and language.
- Translation by Regulatory-Experienced Linguists — Native-speaking translators with regulatory affairs and life sciences expertise translate the content, never machine translation.
- Independent Editing — A second qualified linguist reviews the translation against the source for accuracy, terminology consistency and register.
- QRD & Regulatory Template Compliance Check — We check that translated product information conforms to the relevant national QRD template and formatting conventions before delivery.
- Proofreading & QA — A final quality check confirms formatting, completeness and compliance with any client-specific style requirements.
- Delivery & Certification — Documents are delivered in the required format, with a signed certificate of accuracy where needed for regulatory submission.
Why Sponsors and Regulatory Teams Choose TranslationsInLondon
ISO 17100-aligned process — Every project follows a structured translate–edit–proofread workflow.
Human translation only — No machine translation is used on regulatory submission content; every word is translated and checked by qualified linguists.
QRD template & formatting expertise — Hands-on experience preparing and reviewing QRD-compliant product information for major life sciences LSPs.
220+ languages — Coverage for filings across multiple markets and regulators.
Life sciences specialists — Our linguist network includes translators experienced in pharmacovigilance, clinical trials and medical device documentation.
ITI Corporate Member — TIL is a Corporate Member of the Institute of Translation and Interpreting.
Confidentiality as standard — NDAs and secure file handling for every regulatory engagement.
Frequently Asked Questions
Do you translate CTD/eCTD dossiers into multiple languages at once?
Yes. We regularly manage multi-module, multi-language dossier translations with a single point of contact coordinating terminology consistency across all languages and modules.
Do you check translated product information against QRD templates?
Yes. Our team has direct experience with QRD template review and formatting conventions and checks translated SmPCs, PILs and labelling text against the relevant national template before delivery.
Can you handle regulatory queries and responses on tight deadlines?
Yes. We understand that regulatory correspondence often comes with short statutory response windows and can prioritise these translations accordingly.
Do you use machine translation for regulatory submissions?
No. All regulatory submission translation at TIL is carried out by qualified human linguists. We do not use machine translation for this type of content.
Do you provide certified translations for submission?
Yes. We provide a signed certificate of accuracy with every regulatory submission translation where one is required.
What languages and regulatory markets do you cover?
We translate to and from 220+ languages, covering submissions to the MHRA, EMA and other national regulators. Get in touch with your target markets and we’ll confirm coverage and turnaround.
Can you handle national comments during a decentralised or mutual recognition procedure?
Yes. Where a health authority raises linguistic comments on a translated SmPC, PIL or labelling text during the national phase of a DCP or MRP, we can turn around amendments quickly, working from the same product-specific glossary and translation memory used for the original submission to keep terminology consistent across the correction cycle.
Ready to discuss your regulatory submission translation needs?
Whether you’re preparing a single-market filing or a multi-country marketing authorisation application, our team can scope your translation requirements and provide a clear quote.