Life Sciences Translation Services
One accurate, accountable language partner for the entire life sciences industry — pharmaceutical, biotechnology, medical device, and clinical research. The Translation Company is a women-owned (WBENC-certified) US firm that has translated regulated life sciences content since 2005. As breakthroughs in the field grow, so does the need for international collaboration, and that collaboration depends on getting the language exactly right.
Operating to ISO 9001 and ISO 17100 standards · Women-owned (WBENC) · Serving regulated teams since 2005 · Last updated June 2026
Book a consultation with our CEO, Camila Saunier — a working session about your language program, not a sales pitch.
No room for error in life sciences translation
Science- and health-based organizations have very little room for error. In the pharmaceutical field, a single misspelling in instructions or ingredients can jeopardize patient safety; in a clinical trial or a device submission, an inaccurate term can fail an audit or derail a study. Sensitive content has to be translated precisely, which is why life sciences work belongs with expert human linguists, not unsupervised machines. We make sure the translation adheres to the source exactly and reads correctly for the regulations and conventions of the target market. A mistake in a regulated life sciences document is rarely just a typo; it can mean a costly re-submission, a delayed launch, or harm to a patient, which is why review and subject-matter expertise are built into every project rather than bolted on at the end.
The life sciences we serve
Life sciences is an umbrella over several regulated fields, and we have a dedicated team and a dedicated page for each:
- Pharmaceutical translation — drug labels, SmPCs, package inserts, submissions, and pharmacovigilance.
- Clinical trial translation — protocols, informed consent forms, CRFs, and linguistic validation.
- Medical device translation — instructions for use, labeling, and software under EU MDR and IVDR.
- Biotechnology translation — research, patents, and laboratory documentation.
What we translate for life sciences
Across those fields, regulated content moves constantly across borders. We routinely translate:
- Regulatory submissions and dossiers (FDA and EMA)
- Clinical trial documentation, protocols, and research findings
- Journal articles, study reports, and scientific research
- Drug and device labeling, instructions for use, and packaging
- Toxicological, biological, clinical, and pharmacological information
- Manufacturing SOPs, quality records, and patents
- Investor and partner documentation for cross-border collaboration
Many life sciences programs run in several languages at once, so we let you translate a single document into multiple target languages simultaneously — quicker turnarounds, consistent terminology, less time lost. One accountable partner across pharma, biotech, devices, and clinical research keeps that terminology and quality consistent across your entire life sciences portfolio.
Regulatory and quality standards
Our processes operate to ISO 9001 (quality management) and ISO 17100 (translation services), and we align to the frameworks our clients answer to — the FDA, the European Medicines Agency (EMA), the EU Medical Device Regulation (EU MDR) and IVDR, and ISO 13485 for medical devices. Where a submission or ethics committee requires it, we provide a signed certificate of accuracy. Confidential research and regulatory data is handled securely, never pushed through public machine-translation tools.
Why life sciences teams choose us
- Women-owned and WBENC-certified. A real advantage for life sciences supplier-diversity programs.
- Principal-level accountability. You deal with ownership, not a rotating account manager, and qualified buyers can speak with our CEO directly.
- Human expertise, AI used with judgment. A subject-matter linguist translates and a second reviews; we never assign a project to a linguist who is not qualified in the relevant field.
- We take the time to understand. Two life sciences companies rarely translate for the same reason, so we learn your needs, terminology, and the specifics of each project before we start.
- Faster turnaround. We consistently deliver 30–50% faster than the industry standard, without skipping review.
The regulatory landscape we work across
Life sciences is really a set of overlapping regulatory worlds, and translation has to respect each one. Pharmaceutical product information follows the EMA’s QRD templates across the EU’s official languages; clinical research answers to ICH E6(R3) Good Clinical Practice and the EU Clinical Trials Regulation; medical devices live under EU MDR and IVDR, where each member state sets its own language requirements; and quality systems run to ISO 9001, ISO 17100, and ISO 13485. A misstep in any of them — a mistranslated dosage, an unreadable consent form, an instruction for use missing a required language — can mean a delayed submission or a market you cannot enter. The advantage of one partner across pharmaceutical, clinical, device, and biotech work is that the terminology, the quality system, and the accountability stay the same as your content moves from the lab to the clinic to the market.
Frequently asked questions
Which life sciences fields do you cover?
Pharmaceutical, biotechnology, medical device, and clinical research, plus the regulatory, medical, and scientific content that supports them.
Do you follow life sciences regulations?
We align to FDA, EMA, EU MDR/IVDR, and ISO 13485 expectations, and our processes operate to ISO 9001 and ISO 17100. A certificate of accuracy is available on request.
Can you handle multi-language programs?
Yes. We translate a document into many languages at once, with enforced terminology and dedicated project management for consistency across a program.
Do you use machine translation?
Only with judgment, and never unsupervised on regulated content. A qualified human linguist translates or post-edits, and a second reviews every file.
Explore our life sciences services
- Medical & life sciences translation — our full medical translation practice.
- Pharmaceutical translation
- Clinical trial translation
- Medical device translation
Talk with us about your life sciences program
Start with a conversation, not a price tag. Book a complimentary strategy session with our CEO, Camila Saunier, best suited to life sciences organizations looking for a long-term partner. Have documents ready? Email [email protected] or call 800.725.6498.