Life science translation experts

Translations for EMA Submissions

Any company wishing to market a medicinal product in the EU has to submit an MAA (Marketing Authorization Application) to the EMA (European Medicines Agency). Given the multinational, multi-language nature of the EU, these submissions require translation into up to 25 languages, all of which must follow strict formats and formalities, and are often required within extremely tight timelines.

Conversis has been helping our clients navigate the complexities of translating EMA submissions for over 20 years. We even acquired a specialist regulatory agency back in 2021 to further expand our offering in this area. Our team of regulatory and language experts will be able to guide you through the challenges of EMA submission, using the workflows, tools, and strategies we have built over our two decades of experience.

What are the EMA Translations Guidelines?

The EMA requires submissions under the centralized procedure to be translated into all 25 official EU languages. These translations must follow strict formats, including QRD templates and MedDRA terminology, and be produced by reputable providers with medical and regulatory expertise.

Conversis meets all of these requirements. We’re ISO-certified, work exclusively in life sciences, and have thousands of linguists who perform this highly-specific type of translation every single day.

We’ve trained our AI to apply QRD and MedDRA rules consistently, and we’ve been managing these complex multilingual submissions for decades.

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EMA Translation Services We Offer

QRD compliance checks
Common technical document (CTD) translation
Translation of product information, including:
- Summaries of product characteristics (SmPCs)
- Patient information leaflets (PILs)
- Packaging and labeling documents
Updates pre and post opinion
Affiliate review changes
Member State review changes
Direct liaison with Member States
Certification

…and more!

Why Work With Conversis.

Specialists in life sciences

Providing regulatory services since 2003

3,000+ linguists

People on the ground in all EU countries

All linguists are subject matter experts

Certified ISO 9001, 17100 & 27001

Regularly handle 25-language projects

Track record in 50+ therapeutic areas

Coverage of entire submission process

AI tools developed for regulatory challenges

Translation Process

Our Translation Process For EMA Submissions.

Our standard translation process for EMA submissions runs as follows:

Day 180

Though we have been advising our client on timelines and approach long before now, this is when the main translation work begins, i.e., 30 days before Opinion. We translate, review, and QA the latest version of the English text into the 25 languages required. Each language is handled by two linguists: a specialist translator and an independent reviewer, both native speakers with regulatory expertise.

Day 210 – Opinion

The CHMP issues its final opinion on the English source. If amends have been requested, we make relevant changes to all translated content, and deliver to our client, allowing them time to review before submitting.

Day 215 – Day+5

This is the day on which our client must submit translations to the Member States for review, 5 calendar days after Opinion.

Day 216-229

The Member States review the translations during this period. In case of any linguistic changes or queries, our client either puts us directly in touch with Member States or they manage the process themselves with reference to us, until we reach a final multilingual submission.

Trusted by organizations all over the world

What our clients say about working with us.

“I know some of the requests on these studies have not been typical and we have asked a lot of Conversis, but you really have stepped up and delivered. With your attention to detail, knowledge of the processes, diligence, and hard work to ensure the job gets done, you have made a significant impact on the work we are able to deliver here at IQVIA.”

Shelby Terry, Senior Patient Recruitment Specialist at IQVIA

“The team was always approachable throughout the entire project and worked effectively so that we were able to meet our tight deadline. The linguist’s understanding of the biology and technical aspects of the project resulted in the production of a highly competent translated document. We can therefore only recommend their work.”

Silke Fuchs, Regulatory Scientist at Target Malaria

“I really appreciate you looking for ways to get this project over the line, and for your patience in explaining the processes to me. You guys make translations so much less stressful than my experiences before. Thank you!”

Key Account Manager, Global Pharmaceuticals Company

Case Studies.

EMA Translation Services For All EU Languages.

Our linguists are native speakers living in-country, covering all regions and languages of the EU.

EU Languages Required by the EMA

Bulgarian
Croatian
Czech
Danish
Dutch
Estonian
Finnish
French
German
Greek
Hungarian
Icelandic
Irish
Italian
Latvian
Lithuanian
Maltese
Norwegian
Polish
Portuguese
Romanian
Slovak
Slovenian
Spanish
Swedish

Get in touch to discuss your translation needs.

If you would like a quote for our services or have a question we may be able to help with, please complete the form and we will get back to you as soon as possible.

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FAQs About EMA Translations.

What are the translation requirements for EMA submissions?

The EMA requires translation by medical and regulatory specialists into all 25 official EU languages, MedDRA terminology and QRD templates must be adhered to, and all language versions must reflect any changes made following Opinion.

What are the common challenges for EMA translations?

EMA submission content is highly-specific and must be translated in a very particular way. Poor or inexpert translations by non-specialist linguists can cost you dearly, both in terms of time and money, especially if submissions are rejected and you have to begin the entire process again.

Similarly, the requirements of the EMA are completely inflexible. Non-specialists may be ill-equipped, for example, for the 5-calendar-day window to implement amends, and late translations can cost you just as dearly as low-quality ones.

What EMA translation services do you offer?

We offer a full suite of language services for EMA submissions, including QRD compliance checks, translation and review of product and technical information, updates, implementation of changes, and certification, as well as direct liaison with Member States.