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What Is an In-Country Review (ICR)?

An in-country review (ICR) is a critical quality control step in the life sciences translation process where bilingual subject matter experts located in the target market evaluate translated content for linguistic accuracy, regulatory compliance, and cultural relevance. These reviewers validate whether the translations align with local terminology, healthcare practices, and submission expectations.

ICR is especially important for regulatory, clinical, and patient-facing documents, where even minor inconsistencies can lead to submission delays, market rejections, or safety concerns. Common materials requiring ICR include informed consent forms (ICFs), drug labeling, instructions for use (IFUs), investigator brochures (IBs), and electronic clinical outcome assessments (eCOAs).

Unlike general linguistic review, which focuses on grammar and flow, ICR emphasizes market-specific terminology, clinical appropriateness, and alignment with regional regulatory standards. It also differs from back translation, which is a separate method used primarily for validating equivalence in highly sensitive or high-risk content.

Leading regulatory authorities, including the FDA, EMA, PMDA, and NMPA (formerly CFDA), expect sponsors to submit translations that reflect country-specific language usage. Incorporating in-country review into your workflow helps ensure these expectations are met. ICR also supports ISO 17100 standards for translation quality and complements quality management systems such as ISO 9001:2015.

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Why In-Country Review Matters in Life Sciences

In-country review plays a critical role in ensuring the accuracy and suitability of translated content for regulatory, clinical, and patient-facing use. Without proper review by in-market experts, life sciences organizations risk regulatory delays, market rejections, and compliance issues that can impact approval timelines and patient safety.

Incorrect or inconsistent translations can compromise key documents such as drug labeling, instructions for use (IFUs), patient-reported outcomes (PROs), and informed consent forms (ICFs). These errors may lead to misunderstandings by healthcare professionals or patients and result in regulatory queries or trial holds.

Cultural and linguistic nuances vary significantly across countries. In-country reviewers validate that translated materials reflect local terminology, medical conventions, and regulatory expectations. This includes confirming that clinical terms are used appropriately and consistently in the context of each target market.

Incorporating in-country review also supports market authorization readiness and helps ensure that all content meets the standards of agencies such as the FDA, EMA, PMDA, and NMPA. Most importantly, it contributes to patient comprehension and safety, especially in high-stakes documents used in clinical settings or post-market communications.

By embedding in-country review into the localization workflow, sponsors and CROs gain confidence that their multilingual content meets both regulatory and real-world standards across every target region.

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Sesen’s In-Country Review Process

At Sesen, we follow a structured and transparent in-country review workflow designed to ensure regulatory-compliant, market-ready translations for life sciences content. Our process integrates best practices from ISO 17100-certified translation workflows and adapts to sponsor-specific needs across clinical, regulatory, and commercial documentation.

All content undergoes professional translation by qualified medical linguists, followed by bilingual quality assurance using translation memory, terminology databases, and automated QA tools.

We work with in-country reviewers who are native speakers with domain-specific expertise. Reviewers may include medical professionals, local regulatory affairs specialists, CRO affiliates, or trained bilingual stakeholders.

Each reviewer receives a detailed briefing package, including project objectives, style guides, reference materials, and document-specific context to ensure accurate and meaningful feedback.

Reviewers assess the translated content for linguistic accuracy, cultural appropriateness, local regulatory terminology, and clarity. Comments are captured directly in bilingual files or via secure collaboration tools.

Our linguists carefully implement approved reviewer comments while maintaining consistency with terminology databases, glossaries, and source context. All changes are tracked for transparency.

After updates are made, we perform back-validation to confirm that all revisions are correctly applied and the final deliverable meets both regulatory and linguistic standards. The validated files are delivered in the required format for submission or publication.

Supported Content Types

Sesen provides in-country review services across a wide range of regulated life sciences content. Our reviewers ensure translations are accurate, compliant, and locally appropriate for submission, trial execution, and patient communication.

Ensure that core clinical and safety information is accurately presented in the local language for investigators and ethics committees.

Confirm consistency and clarity in procedural language across regions, including regulatory terminology and country-specific requirements.

Validate patient-facing language for clarity, cultural appropriateness, and compliance with local regulatory expectations.

Review labeling and packaging content to meet country-specific regulatory and safety requirements, including dosage, warnings, and contraindications.

Check that device usage instructions are understandable and properly localized for patient and healthcare provider use in each target country.

Assess linguistic and cultural relevance to preserve meaning and measurement validity in translated questionnaires and scales.

Evaluate electronic interfaces to ensure accurate translation of digital prompts, navigation cues, and assessment content for clinical trials.

Review translated modules of the Common Technical Document for terminology consistency, alignment with local regulatory guidelines, and submission readiness.

Validate technical manuals for regulatory compliance, user comprehension, and alignment with ISO 13485 documentation requirements.

Who Performs the Review?

Sesen partners with qualified in-country experts who bring both linguistic fluency and subject matter expertise to the review process. These professionals ensure that translations meet clinical, regulatory, and cultural standards specific to each target market.

Physicians, pharmacists, or clinical researchers who validate medical terminology and context in the local language.

Regulatory personnel familiar with regional submission requirements who confirm that translations align with country-specific terminology and formatting conventions.

In-country personnel involved in the clinical trial who assess operational clarity and compliance of study documentation.

Reviewers follow a standardized feedback framework developed by Sesen to capture comments on linguistic accuracy, terminology, and usability.

We coordinate with sponsor-nominated reviewers, such as local market representatives or in-house QA staff, to align feedback and final approval workflows.

According to internal audit data and industry reports, up to 80 percent of submission delays are linked to preventable issues in translated content. In-country review helps identify and resolve these risks early in the process.

Technology-Driven ICR Workflows

Sesen leverages secure, cloud-based technologies to streamline the in-country review process and improve collaboration, traceability, and review accuracy. Our platform supports flexible workflows that adapt to each sponsor’s documentation requirements and regulatory timelines.

Reviewers can provide feedback through a secure online portal or directly within bilingual, comment-enabled PDF files. This allows for efficient review cycles with full context visibility.

All documents are shared through encrypted, access-controlled environments hosted on AWS. This ensures data confidentiality, version control, and audit readiness.

All reviewer comments are tracked with timestamps and user IDs. Implementation logs document how each comment was addressed, supporting transparency and compliance with quality assurance protocols.

Reviewers and linguists work from aligned bilingual displays, allowing for faster comparison of source and target content and reducing the risk of misinterpretation.

Reviewer input is validated against client-approved translation memory, terminology databases, and style guides to maintain linguistic consistency across documents and projects.

Our technology-enabled workflows allow sponsors, CROs, and affiliate reviewers to collaborate seamlessly while maintaining full control over content quality and data security.

Global Coverage and Language Support

Sesen provides multilingual in-country review services across more than 150 languages, supported by native-speaking linguists and medical professionals with deep subject matter expertise. Our reviewers are selected based on their knowledge of local healthcare systems, clinical practices, and regulatory requirements.

We maintain broad geographic coverage across all major life sciences markets, including:

  • North America
    United States, Canada, Mexico
  • European Union and United Kingdom
    All official EU languages, including German, French, Spanish, Italian, Dutch, Polish, and the Nordic languages
  • Asia-Pacific
    Chinese (Simplified and Traditional), Japanese, Korean, Thai, Vietnamese, Bahasa Indonesian, and others
  • Latin America
    Spanish (LatAm), Portuguese (Brazil), and region-specific variants
  • Middle East and North Africa (MENA)
    Arabic (Modern Standard and regional dialects), Turkish, Farsi, and Hebrew

Our workflows align with the specific requirements of global health authorities, including the EMA, FDA, PMDA, ANVISA, and SFDA. This allows us to provide localized content that meets the terminology, format, and compliance expectations of each regulatory body.

By combining linguistic accuracy with regulatory precision, Sesen helps ensure your translations are fit for submission, patient use, and market entry in every region you serve.

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Why Choose Sesen for In-Country Review?

Choosing the right partner for in-country review is critical to ensuring the accuracy, compliance, and market readiness of your life sciences translations. Sesen combines deep industry specialization with global reach and certified quality processes to deliver reliable multilingual review support across every stage of your clinical and regulatory workflow.

Sesen specializes exclusively in life sciences translation. Our team understands the clinical, regulatory, and scientific nuances that drive accurate and compliant multilingual content.

We operate under ISO 17100, ISO 13485, and ISO 9001 certified processes to ensure quality, consistency, and full traceability across every in-country review project.

Our network includes professional native reviewers, clinicians, and regulatory experts across all major therapeutic areas and geographic regions. This ensures medical accuracy and market alignment.

In-country review is seamlessly integrated into the translation, editing, and proofreading (TEP) cycle. This streamlines project timelines and eliminates redundant review layers.

All content is managed through a secure AWS-hosted infrastructure that is HIPAA compliant and suitable for GxP-governed documentation, ensuring full data protection throughout the workflow.

We tailor reviewer onboarding, context briefings, and feedback templates to match your documentation goals, internal SOPs, and regulatory requirements. Our flexible model supports collaboration with sponsor-nominated reviewers or affiliate teams.

Case Study: Regulatory Submission Translation for Global Biopharma

A global biopharmaceutical company engaged Sesen to support the translation and in-country review of critical regulatory documents as part of a multi-country submission.

Sesen coordinated end-to-end project execution across multiple language pairs, integrating in-country reviewers from the client’s affiliate network and Sesen’s medical linguist pool. By embedding in-country review into the translation lifecycle, the project achieved faster approval cycles, reduced review iterations, and improved consistency across clinical and labeling documentation.

This collaboration ensured compliance with EMA and PMDA submission requirements while helping the sponsor meet its regulatory timeline for product launch.

Read the full case study →
Regulatory Submission Translation for Global Biopharma

Frequently Asked Questions

While not explicitly required by the FDA, in-country review is strongly recommended for ensuring that translated materials are accurate, culturally appropriate, and aligned with local terminology. Many sponsors include ICR as part of their quality process to reduce the risk of agency queries or rejections.

Reviewers should be native speakers with subject matter expertise in the therapeutic area or document type. Ideal candidates include in-market clinicians, regulatory affairs professionals, CRO personnel, or trained bilingual staff with knowledge of clinical and regulatory terminology.

Sesen maintains a global network of qualified reviewers and can provide in-country or near-market experts when internal resources are not available. We also offer training and onboarding for sponsor-nominated reviewers to ensure consistency in the feedback process.

Yes. We frequently collaborate with sponsor affiliates, country managers, or local QA teams. Sesen provides customizable templates, reviewer instructions, and implementation workflows to ensure seamless integration and audit-ready documentation.

Typical ICR cycles range from 3 to 7 business days depending on document length, language, and reviewer availability. Timelines may vary for high-volume projects, multi-language batches, or review rounds involving multiple stakeholders.

Related Services

Explore additional services that complement in-country review and support your global life sciences initiatives:

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Ensure your clinical, regulatory, and patient-facing content is accurate, compliant, and market-ready. Sesen’s multilingual in-country review services help you reduce risk, accelerate approvals, and maintain consistency across regions.

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