Make linguistic review the easy bit of your MAA with submission-ready pharmaceutical translations by MediLingua.
With the clock ticking on market exclusivity, the last thing you want is for a regulatory authority to query a translation in your submission. Delays like this eat into your return on investment.
Yet a query like this can easily happen. Linguistic review is a tricky business. How do you juggle all those languages? How do you find translators who understand the drug approval process? And how do you do it in just 5 days?
With our pharmaceutical translation services, you don’t have to.
The EMA only gives you a short window (from days 210 to 215) to translate the final version of your primary product information into your market languages.
That’s why our pharmaceutical translators start translating your product information early, before it’s finalised. If the EMA requests changes, we quickly update your translations and get them back to you ready for submission.
MediLingua is certified to ISO 9001 and ISO 17100, so we can give you a translation certificate to prove the authenticity of your translation and speed up the approval of your submissions.
At MediLingua, we offer a pharmaceutical translation service for drug manufacturers just like you. We translate product information and other pharmaceutical documents into all major languages. And we’ve been doing it since 1996.
Hundreds of companies have trusted us to translate their MAA and other regulatory documentation. And if we’ve helped them get their products through approval and into the market, we can help you too.
Our translations are accepted by all national and international health authorities. So you can use them directly in your regulatory submissions, secure in the knowledge that you are safe from queries and hold-ups.
No need for passwords or anonymous platforms. With us, it’s a single address, a single project manager, and a single team of translators to give you ease of use and consistent results.
Other companies cater to every industry out there, from betting to fashion. At MediLingua, our focus on medical and pharmaceutical content means you get an expert translation you can immediately use with confidence.
You may feel hesitant about handing over your sensitive product materials to outsiders. Below, you’ll find reassurance about common concerns that clients have. If you’ve got other questions, let us know.
We specialise in the summary of product characteristics (SmPC), labelling and package leaflet. We also translate other relevant documentation for marketing authorization applications, market launches and regulatory compliance.
We offer pharmaceutical translation services for all major languages in Europe, the Middle East, Asia, Africa, and the Americas. Reckon you’ve got a language we can’t translate? Try us! You’d be surprised.
Yes, they will. At MediLingua, our multi-step quality control process has been certified to ISO 9001:2015 and ISO 17100:2015. This allows us to deliver a translation certificate to prove the authenticity of your translation. This certificate is the seal of approval that regulatory authorities are looking for, meaning that you can use our translations directly in your regulatory submissions to health authorities.
We know how it is: you’ve invested heavily in R&D and clinical trials. You’ve generated data to bring a product to market before anyone else. You really don’t want your hard-earned advantage to fall into the wrong hands.
Rest assured, your documents are safe with us. To keep them protected, we upload and download files securely using SharePoint. Our network is protected using a fully managed Unifi USG Pro firewall. This firewall includes systems that detect and prevent intrusion. Our security logging is also actively monitored. Additionally, all our translators sign a confidentiality agreement before working on your documents. If you want to know more about our confidentiality policy, contact us.