Pharma & Biotech

Regulatory Submission Translations

Unlike most translation agencies, Conversis works exclusively in life sciences, and has done so since 2003. We have translated and revised countless regulatory submissions in our 20+ years in the industry, and back in 2021, we acquired regulatory specialists, Zebra Translations, to further reinforce this expertise.

These days, we have all the sector-specific tools and processes, specialist linguists, and in-house, hands-on experience necessary to offer a regulatory translation service that is second to none.

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Looking for regulatory translation services for medical devices? Please visit our regulatory for medical devices page.

Pharma & Biotech

Our Regulatory Translation Expertise.

Getting regulatory approval to market your products can be a long and arduous process. Between creating all the relevant documentation, ensuring it adheres to appropriate templates and guidelines, and identifying the exact requirements for each regulatory body you’re applying to, it can be easy to push something like translation out to the last minute.

At Conversis, we embed into your workflows to ensure seamless translations at every step of the marketing authorization journey. We do this work every day, so we know exactly when you need us, we have honed our processes to comfortably manage extremely tight timelines, and we have specialist linguists in 330+ language combinations, including all languages required by the EMA (European Medicines Agency).

So you can take translation off your list of things to worry about when it comes to regulatory submissions.

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We Offer Regulatory Translation For

Submissions to all major regulatory bodies, including the EMA, FDA, and PMDA
Common technical documents (CTDs)
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

…and more!

Why Work With Conversis.

Specialists in life sciences

Providing regulatory services since 2003

Acquired regulatory specialist in 2021

All processes created for life sciences

3,000+ linguists

330+ language combinations

People on the ground in 110 countries

All linguists are specialists in life sciences

ISO 9001, 17100 & 27001 for quality, best practice & information security

Track record in 50+ therapeutic areas

Coverage of entire submission process

AI tools developed for regulatory challenges

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Translation Process

Our Regulatory Translation Process.

Because regulatory content is so specific, Conversis has a dedicated team of in-house project managers and regulatory specialists who do this work every day. They will work with you to understand your products, timelines, and communication preferences to ensure your submissions run smoothly, regardless of how many markets and authorities are involved.

As an example, our standard regulatory translation process for the EMA generally runs as follows.

Day 180

Though we have been advising our client long before now, this is when the main translation work begins, i.e. 30 days before Opinion. We translate and review the latest version of the English text into the 25 languages required.

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 so they can 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. In case of any linguistic changes or queries, if they wish, our client can put us directly in touch with the Member States.

Trusted by organizations all over the world

What our clients say about working with us.

“Working with the Conversis team has been a very positive experience. They are flexible, proactive, attentive to our needs, consistently respectful of deadlines, and dedicated to delivering the best possible outcome”

Survey Project Manager at EURORDIS

“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

Case Studies.

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Regulatory Translation Services in Over 330 Language Combinations:

Our extensive network of linguists spans the globe, with experts residing in their respective countries, covering all regions worldwide. This means we can help you meet submission requirements for all major regulatory bodies internationally, including the EMA, FDA, MHRA, and PMDA. And we offer translation services in over 330 language combinations.

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Frequently Asked Questions About Regulatory Submissions.

How do you ensure your translation work is regulation-compliant?

The Conversis team performs regulatory translation work every day, and has done so for 20+ years. We have a specialist team in-house who are responsible for this work and for staying on top of changes to global and local regulations. They ensure our custom AI is up to date with the latest versions of any sector-specific tools and resources, such as QRD templates and MedDRA terminology, and utilize our proprietary workflow solutions to complete rigorous compliance checks.

What are the common challenges or risks associated with regulatory translations?

Regulatory content is highly-specific and so must be translated in a very particular way. Generalist agencies and linguists, who do not have the requisite level of expertise in regulatory translation, are unlikely to be familiar with the tools, templates, and terminology required for this type of content. 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 regulatory bodies are hyper-specific and 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.

How long do your regulatory translation services take?

We assess each new project to determine costs and timelines. A standard turnaround is about 2,000 words per day for translation and 1,000 words per hour for review. However this can vary depending on the languages involved, the complexity of materials, and the volume. With regulatory materials, timelines are often defined by the body you are submitting to, in which case we will apply a workflow specifically designed around that body’s timelines and requirements.

What qualifications/certifications/accreditations do you have?

At Conversis, we have an established quality management system that underpins every level of the business. We are certified to the international standards for quality (ISO 9001), translation services (ISO 17100), and information security (ISO 27001); evidence of our commitment to delivering secure, high-quality translations and rigorous quality management.