We combine regulatory expertise, smart workflows, and ISO-certified processes to keep your translations accurate, efficient, and audit-ready
Regulatory affairs
Smart translation for smooth regulatory affairs
Compliance without
the headache
A single error in a translation can delay approvals, raise compliance issues, or lead to costly rework. With our services, we can help you submit new drug applications and design custom workflows that reduce delays for submissions to regulatory bodies, including institutional review boards and ethics committees. Wherever you are in the journey – from application to marketing – we’ll make sure that your translations are correct, compliant, and ready to submit across all markets.
Translations for any regulatory affair
Our expertise extends across the entire product lifecycle, from the initial application stages through to post-marketing activities. We’ll collaborate with your team to design custom workflows, allowing you to navigate the complexities of global submissions with confidence. With over 15,000 linguists and 330+ language pairs, we can help make sure your translation is accurate and follows local regulations. Whatever the content.
We’re profoundly familiar with MedDRA terminology, EDQM standard terms and QRD templates. We’re also a member of ISPOR and follow these standards:
– ISO 17100 – Translation services
– ISO 9001 – Quality management systems
– ISO 13485 – Medical devices
– ISO 18587 – Machine translation post-editing
Trusted by Pharma and CROs worldwide
In our 15 years of experience, we’ve helped pharma companies and CROs to continuously improve their translation process to make it as painless as possible.
Submissions.
Translate common technical documents (CTD modules 1-5), marketing authorisation applications (MAA), new drug applications (NDA), biologics license applications (BLA).
Documentation.
Help patients understand their treatment. We can cover product information (PILs, SmPCs, and labelling), and clinical reviews.
Compliance.
We make sure your translations are ready for any market. We follow local regulatory guidelines and make sure your formatting and terminology are always consistent.
Labelling.
Get help with labelling and layout for prescription drugs. Review aspects like dosage, storage, adverse effects and contraindications in all markets