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 12,000 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 20 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
Frequently Asked Questions
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Does Geo Language Services follow ISO-certified processes?
Yes. Regulatory translation operates under our ISO 9001:2015 and ISO 17100:2015 certifications — qualified linguists, mandatory independent revision, documented quality checkpoints, full audit trail. Documentation is provided as standard to support submission audit and inspection readiness.
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How does Geo Language Services avoid costly rework?
Through upfront scoping, terminology management, applicable-template awareness and proactive flagging of issues. Where source content has problems that will affect downstream submission (ambiguous claims, inconsistent terminology, structure that doesn’t match the target regulatory authority’s expectations), we flag at the start rather than discover at submission. Rework on a missed regulatory deadline is expensive; flagging up front is not.
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Can Geo Language Services translate PILs?
Yes. We translate Patient Information Leaflets against the harmonised QRD template, apply target-language conventions for readability and accessibility, typeset to regulatory layout requirements, and provide user-testing-ready versions where readability testing is part of the submission pathway.
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Is Geo Language Services able to help with labelling and layout for prescription drugs?
Yes. Prescription drug labelling — SmPC, PIL, cartons, blister labels, vial labels, mock-ups for regulatory submission — is translated, typeset and reviewed against target-market requirements (EU QRD template, MHRA expectations, national variations). We deliver in print-ready format and can provide mock-ups for the regulatory pack.
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Does Geo Language Services translate new drug applications?
Yes. We translate the full set of dossier components: eCTD modules (Modules 1–5 as required), IND/CTA, IMPD, investigator brochure, clinical study reports, summary documents, labelling, and any country-specific national submission components. Workflows support the harmonised structure expected by the FDA, EMA, MHRA and other major agencies.