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What Is Linguistic Review

What Is Linguistic Review?

Linguistic review is the final quality assurance step in the translation process, performed by in-country native speakers with subject matter expertise. It involves a detailed evaluation of translated content to confirm linguistic accuracy, correct use of terminology, compliance with local regulatory standards, and appropriateness for the target audience.

This process is especially critical in life sciences, where even minor inconsistencies can affect regulatory acceptance, patient comprehension, or brand reputation. Linguistic review ensures that translated materials are not only correct in meaning but also aligned with regional language preferences, tone of voice, and medical or scientific conventions.

Linguistic review services typically include:

  • Validation of technical and scientific terminology
  • Compliance review for local regulatory or labeling requirements
  • Review of cultural relevance and target audience clarity
  • Adaptation of brand tone and messaging for local markets
  • Coordination with affiliate teams and market reviewers

Linguistic review is often part of a broader quality process that may include in-country review, affiliate feedback workflows, or translation validation depending on your organizational structure.

For structured affiliate input and multilingual feedback management, Sesen also provides In-Country Review Services.

Our services support companies and institutions in pharmaceuticals, medical devices, diagnostics, biotechnology, contract research, and public health, helping them navigate global compliance standards with linguistic accuracy and sector-specific expertise.

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Why Linguistic Review Is More Important Than Ever

Why Linguistic Review Is More Important Than Ever

As global life sciences companies adopt new translation workflows, the demand for expert linguistic review has never been greater. Many organizations now rely on AI-generated content or internal language resources to speed up translation and reduce costs. However, these solutions often lack the precision and contextual accuracy required for high-stakes materials in regulated environments.

At the same time, regulatory agencies across the globe are tightening requirements for language quality, especially in clinical, regulatory, and labeling documentation. A single terminology error or regional inconsistency can delay approval timelines or compromise patient safety.

Linguistic review bridges this gap. By engaging native-speaking subject matter experts to validate translated content, organizations can uphold both speed and quality without sacrificing compliance. It is now considered a best practice for critical materials such as:

  • Clinical trial documentation including protocols, ICFs, and eCOA outputs
  • Regulatory submissions such as IFUs, SmPCs, and drug labeling
  • Patient-facing and marketing materials across international markets

As AI and internal translation workflows continue to evolve, professional linguistic review ensures that every word is accurate, compliant, and appropriate for its intended audience.

Use Cases for Linguistic Review in Life Sciences

Use Cases for Linguistic Review in Life Sciences

Linguistic review plays a critical role across the entire life sciences content lifecycle, helping ensure language accuracy, regulatory alignment, and local market readiness. Whether content is created in-house, translated by a third-party vendor, or generated using machine translation, Sesen provides targeted review support tailored to each document type and function.

  • Summary of Product Characteristics (SmPCs)
  • Instructions for Use (IFUs)
  • Patient Information Leaflets (PILs)
  • Device labeling and packaging content
  • CE marking technical documentation
  • Informed Consent Forms (ICFs)
  • Electronic Clinical Outcome Assessments (eCOA)
  • Patient diaries and logs
  • Site instructions and recruitment brochures
  • Multilingual websites and landing pages
  • Product brochures and fact sheets
  • Video scripts and subtitles for promotional materials
  • Press releases and social media copy
  • Standard Operating Procedures (SOPs)
  • Staff training manuals and onboarding materials
  • eLearning modules for global teams
  • Health and safety documentation
  • Human review of machine-translated (MT) or large language model (LLM) outputs
  • Validation of terminology and style consistency
  • Correction of AI translation errors or omissions
  • Adaptation for compliance and cultural appropriateness

Sesen provides linguistic review services regardless of how the initial translation was performed. We routinely support clients using in-house teams, localization platforms, or third-party providers.

Our Global Linguistic Review Workflow

Our Global Linguistic Review Workflow

Sesen’s global linguistic review workflow is designed to deliver high-quality, regulatory-compliant translations that are ready for submission or public release. Every step is supported by expert linguists, structured processes, and technology-driven tools to ensure consistency and control across languages and markets.

Workflow Overview:

Clients submit both the source content and initial translations, which may originate from internal teams, third-party vendors, or AI systems.

A qualified linguist with subject matter expertise in the target domain and country is assigned. Reviewer selection is based on language, therapeutic area, and regulatory experience.

The linguist conducts a detailed evaluation of the translation for:

  • Linguistic and factual accuracy
  • Terminology consistency using approved glossaries
  • Alignment with tone, voice, and style guides
  • Compliance with local regulatory and cultural standards

When needed, Sesen coordinates with in-country affiliates or client reviewers to incorporate market-specific feedback and align with internal preferences.

The final version is delivered with tracked changes, comments, or as a clean file, depending on client preference. A quality checklist can also be included for audit trail purposes.

Additional Capabilities:

  • Review teams have access to Sesen’s centralized terminology databases and validated style guides to ensure consistency across regions and content types.
  • We support review in over 150 languages, including multilingual coordination for simultaneous market launches.

This structured workflow helps global life sciences teams maintain translation accuracy, reduce compliance risks, and accelerate time to market across international operations.

Sesen vs. Generic Review Vendors

Choosing the right linguistic review partner is critical for life sciences companies working in regulated markets. While many language providers offer basic proofreading or general review services, few have the specialization required to meet the strict demands of medical, clinical, and regulatory content.

Sesen delivers expert-driven review workflows tailored specifically for life sciences. Our in-country linguists, regulatory expertise, and support for AI-generated content set us apart from generic vendors.

Feature Sesen Generic Vendors
Life Sciences Specialization Deep expertise in pharma, medtech, CRO, biotech Generalist approach with limited domain knowledge
Regulatory Experience Proven track record with FDA, EMA, CE submissions May lack familiarity with compliance requirements
In-Country SME Reviewers Native-speaking subject matter experts Mixed quality, not always local or qualified
AI-Content Validation Expertise Structured workflows for LLM and MT review Rarely support machine-generated content QA
ISO 17100 & 9001 Certifications Fully certified for translation quality and process control Certification status varies by vendor

Sesen provides a higher standard of linguistic review that aligns with regulatory expectations and scientific accuracy. Whether you are preparing content for submission, publication, or patient-facing communication, our specialized approach ensures your translations are ready for the global market.

Common Client Scenarios We Support

Sesen’s Global Linguistic Review Services are designed to address the evolving needs of life sciences companies operating in multilingual, regulated environments. Below are examples of common challenges our clients face and how we help solve them.

A global medical device company uses internal translation tools to save time but requires expert review before regulatory filing. Sesen provides in-country subject matter experts to validate accuracy, terminology, and compliance before finalization.

A leading biopharmaceutical company struggled with decentralized affiliate review across 25 markets. We implemented a structured linguistic review workflow with consolidated feedback management and standardized terminology to reduce delays and rework.

A European regulatory team preparing CE-marked submissions needed multilingual label validation for EU MDR. Sesen deployed native reviewers familiar with regional labeling regulations to confirm terminology alignment and cross-market consistency.

A CRO working on a global clinical trial received translated eCOA and ICF materials from a vendor but lacked confidence in quality. Sesen performed an independent linguistic review to correct terminology, improve clarity, and ensure readiness for ethics board approval.

These scenarios reflect just a few of the ways we support life sciences clients in maintaining language accuracy, compliance, and operational efficiency across global markets.

Why Choose Sesen for Global Linguistic Review

Why Choose Sesen for Global Linguistic Review

Sesen delivers specialized linguistic review services tailored to the complex demands of life sciences. Our approach combines in-country subject matter expertise, regulatory precision, and secure technology to help clients maintain global quality standards across multilingual content.

Sesen specializes in regulatory, clinical, and commercial content for pharmaceutical, biotech, medical device, and CRO clients. Our team understands the unique language and compliance requirements of the life sciences industry.

We assign native-speaking reviewers with domain-specific knowledge in each target market. Our linguists are trained in therapeutic area terminology and local regulatory expectations.

Our review process is designed to meet the standards of global health authorities, including the FDA, EMA, MHRA, and PMDA. We help ensure that your translations support successful approvals and submissions.

Sesen uses centralized terminology databases, client-approved glossaries, and style guides to maintain consistency across content types and languages. Our review process aligns with your brand voice and scientific accuracy standards.

We validate content produced through in-house teams, third-party vendors, or machine translation systems. Our workflows are optimized for quality control of large language model outputs and automated translation platforms.

Sesen offers a secure cloud-based review environment with version control, tracked changes, and comment histories. This allows clients to audit revisions and streamline feedback cycles with full transparency.

Related Services

Related Services

Clients who engage Sesen for global linguistic review often benefit from the following complementary services:

Get a Quote for Global Linguistic Review Services

Whether you need final QA on AI-translated regulatory content, multilingual validation for clinical trial materials, or affiliate review coordination across global markets, Sesen offers expert linguistic review tailored for life sciences. Our team is ready to support your next project with precision and speed.

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