Pharmaceutical translation services
Drug development moves through many phases, each generating documentation that must meet a different regulatory standard, serve a different audience and hold up under scrutiny in multiple markets simultaneously. Sandberg provides pharmaceutical translation services for companies managing that complexity, supporting regulatory affairs, medical writing and localisation teams from early development through to post-approval obligations.
350+
current clients
30+
years of experience
120+
languages
Pharmaceutical translation services across the drug development lifecycle
Pharmaceutical companies don’t manage translation as a standalone activity. It runs through every stage of development, from first-in-human studies to post-approval safety reporting. The documentation is dense, the terminology is tightly controlled and the regulatory bar for accuracy is high across every market you enter.
Our services are used by regulatory affairs teams, medical writers and localisation managers at companies managing multi-market drug programmes. They form part of our wider medical translation services, alongside support for clinical research and medical device manufacturers.
What pharmaceutical content do you need translated?
- Common technical document (CTD) modules
- Patient information leaflets (PILs) and labelling
- Informed consent forms (ICFs)
- Summary of product characteristics (SmPC)
- Investigator brochures (IBs)
- Adverse event reports (AERs)
- Risk management plans (RMPs)
- Clinical study reports (CSRs)
- Patents and regulatory correspondence
- Medical education and training materials
Get in touch
Find out how our pharmaceutical translation services can support your regulatory affairs, medical writing and localisation teams from early-phase development through global market authorisation and post-approval obligations.
Why pharmaceutical teams work with Sandberg
Terminology control across the product lifecycle
We build and maintain product-specific termbases for each account, validated against your approved source documentation, so the same compound name, the same adverse event term and the same indication reads identically across every language, every document and every submission. As your product moves through development phases, the termbase moves with it.
Traceability across every project and version
Regulatory inspections, notified body reviews and internal audits all require documentation that shows who translated what, when and according to which process. Our ISO 17100-aligned workflows provide that traceability as standard through version control, review records and delivery documentation maintained across every project without additional administrative burden on your team.
Subject-matter expert review
For certain content, you may want reassurance that translated materials accurately convey meaning, not just linguistically, but conceptually. We provide in-country subject-matter experts, including clinical specialists and healthcare professionals, that can ensure terminology accuracy, clinical credibility and country-specific information.
Appropriate use of technology across content
Risk-averse pharmaceutical environments require clarity about where technology is applied and where it is not. We use machine translation with human post-editing for high-volume, lower-risk content with stable, repetitive phrasing. Regulatory submissions, patient-facing materials and safety documentation are always handled with full human translation and specialist review. We are transparent about how that distinction applies to your specific content before work begins.
Read our blog: Where language bottlenecks slow submissions
Most regulatory submission delays attributed to translation are avoidable. This article explores where pharmaceutical regulatory translation breaks down, why issues often surface late in the process and how better planning keeps global submissions on track.
Frequently asked questions about pharmaceutical translation services
They cover the translation and localisation of regulated documentation used throughout the drug development lifecycle, such as regulatory submissions, clinical trial materials, labelling, patient information and safety reporting. Each document type requires specialist linguistic expertise, controlled terminology and processes designed to withstand regulatory scrutiny and audit review.
We translate CTD modules, SmPCs, PILs and regulatory correspondence in line with EMA requirements and equivalent frameworks for other markets. Terminology management ensures consistency across languages and document versions throughout the submission process, and our account managers work to the timelines that regulatory submission windows require. Where urgent turnaround is needed, we have the capacity to respond without compromising review quality.
Yes. For clinical outcome assessments, patient-reported outcomes and other patient-facing content where validation is required, we provide structured back-translation and linguistic validation services with full process documentation. This supports both regulatory submission requirements and sponsor QA expectations.
We use encrypted file transfer, GDPR-compliant data handling and controlled access to linguistic resources. Translation memories are sanitised to prevent storage of personally identifiable or commercially sensitive data, and everyone working on your account operates under strict confidentiality agreements. Data retention and sanitisation policies are available on request.
Other medical translation services
Centralised multilingual support across clinical research, medical devices and pharmaceuticals.
Accurate, traceable translations supporting global studies, ethics submissions and patient communication.
Compliant localisation for IFUs, labelling, regulatory documentation and software interfaces.