Life Sciences & Pharmaceuticals
Compliant. Precise. Audit-ready.
In your industry, accuracy is non-negotiable.
In life sciences, medical devices and pharmaceuticals, a single mistranslated term can delay MDR/IVDR regulatory approval, put patient safety at risk or trigger costly recalls.
Whether you are preparing IFUs, patient information leaflets, clinical trial documentation or regulatory submissions, you need a translation partner who understands both the language and the science – and delivers audit-ready compliance from day one.
In this high-stakes industry, these are the challenges we help the world’s leading life sciences brands overcome every day:
1. Regulatory compliance under constant scrutiny
MDR, IVDR, EMA, FDA, ANVISA – each market has its own evolving regulations.
Missing even a minor requirement can mean rejected submissions, fines or market delays.
✅ SMARTIDIOM’s triple ISO certifications (9001, 17100, 18587) guarantee workflows that are fully audit ready, tailored to each jurisdiction and designed to meet every compliance checkpoint.
2. Complex, high-stakes content
From clinical trial protocols to pharmaceutical packaging, life sciences documentation is dense with specialised terminology and formatting rules. Any inaccuracy can compromise compliance and credibility.
✅ We assign native-speaking linguists with proven medical and pharmaceutical expertise, supported by client-approved glossaries and terminology databases, ensuring perfect accuracy and consistency.
3. Tight deadlines with no margin for error
Regulatory submissions and product launches demand both speed and precision. Missing a deadline can mean lost market share or delayed approvals.
✅ Our AI-powered, human-driven workflows combine ISO 18587-certified MTPE with multi layer QA – delivering high-volume projects quickly without compromising compliance or quality.
4. Confidentiality and data protection
From patient data to proprietary formulations, your content is highly sensitive and must remain secure at all times.
✅ We operate under strict GDPR compliance, with NDA-bound teams and secure encrypted file transfer protocols — ensuring your content never touches unsafe public MT engines.
5. Continuous updates and version control
Clinical and product documentation is constantly updated. Consistency across all languages and versions is essential to avoid compliance issues.
✅ Our advanced terminology management and translation memory systems guarantee alignment and consistency across every update in every market.
Services for Life Sciences & Pharmaceuticals
Certified medical and pharmaceutical translation
Regulatory submission translation & review
(MDR, IVDR, EMA, ANVISA)
Patient information leaflets (PIL) & IFU localisation
Clinical trial documentation translation
Medical device labelling & packaging compliance
Independent Linguistic Quality Assurance (LQA)
Medical marketing and patient-facing content adaptation
Terminology management & glossary creation
Case study: MDR & IVDR compliance at scale
See it in action: SMARTIDIOM's successful implementation of QA processes aligned with EU MDR & IVDR regulations
A major European medical device manufacturer approached SMARTIDIOM needing to ensure complete compliance with MDR and IVDR regulations for their multilingual product documentation.
With the regulatory audits intensifying, the client required absolute accuracy, consistency, and traceability across translations of user manuals, labelling, patient information leaflets and regulatory submissions.
✅ ISO 9001, 17100 and 18587-certified workflows
✅ Multi-layer QA, including linguistic and regulatory compliance checks
✅ Specialised translator training and continuous feedback loop
The result? Zero critical findings, a 30% reduction in overall revisions after initial QA and enhanced client confidence in their multilingual documentation.
FAQ: Life Sciences & Pharmaceuticals
Q1. How do you ensure MDR/IVDR compliance and full traceability?
We run documented, audit-ready workflows with change control, versioned deliverables and in-country SME review. Every file has an audit trail (who, when, what changed) and LQA scores, with CAPA actions where needed.
Q2. Can you provide back translation for safety-critical content (PILs, IFUs, labels)?
Yes. Dual‑linguist back translation with reconciliation notes and variance analysis. We flag any semantic drift and lock approved phrasing into termbases for future updates.
Q3. How do you keep patient data secure?
GDPR‑compliant processing, encrypted transfer, least‑privilege access, NDA‑bound teams and zero use of public MT. Data residency options available on request.
Is your content ready to pass every regulatory audit in every market in which you operate?
and see how SMARTIDIOM can make your life sciences content precise, compliant and market-ready.
