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cmc-document-translation

Expert CMC Documentation Translation for Regulatory Clarity

In the pharmaceutical industry, CMC (Chemistry, Manufacturing, and Controls) documentation plays a pivotal role in regulatory submissions, detailing the composition, manufacturing processes, and quality control procedures of drug products. Regulatory bodies such as the FDA, EMA, PMDA, and NMPA require this information as part of IND, NDA, and MAA filings to assess product safety, efficacy, and consistency.

For global market access, accurate and compliant CMC documentation translation is essential. Inconsistencies or errors in translation can lead to regulatory delays, additional inquiries, or even rejections. That’s why pharmaceutical companies rely on trusted language partners with deep domain expertise.

At Sesen, we specialize in CMC Documentation Translation Services tailored for the life sciences sector. Our linguists combine scientific fluency with regulatory knowledge to deliver precise, high-quality translations that support global regulatory compliance and smooth approval processes. Whether you're preparing a Common Technical Document (CTD) or translating analytical methods and batch records, Sesen provides the accuracy and reliability you need.

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The Importance of CMC Documentation in the Pharmaceutical Industry

CMC (Chemistry, Manufacturing, and Controls) documentation is a critical part of regulatory submissions, detailing a pharmaceutical product’s composition, manufacturing processes, and quality control measures. At Sesen, we understand the central role CMC content plays in ensuring product safety, consistency, and compliance. Regulatory agencies—including the FDA, EMA, PMDA, and NMPA—closely scrutinize CMC sections as part of Common Technical Document (CTD) submissions to determine whether a product meets global GMP and quality standards.

For companies seeking international approvals, accurate and consistent CMC documentation translation is essential. Inaccurate translations can lead to regulatory delays, rejections, or additional agency inquiries. Sesen ensures your CMC documentation is translated with the technical precision and regulatory fluency required by ICH guidelines and other international frameworks. Our expert linguists help pharmaceutical companies achieve faster approvals and smoother global market entry by delivering clear, compliant translations every time.

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Types of CMC Documents We Translate

Sesen provides specialized CMC documentation translation services for a wide range of technical and regulatory materials required throughout the drug development lifecycle. Our expertise covers all components of Chemistry, Manufacturing, and Controls (CMC) to support global regulatory submissions, manufacturing compliance, and product lifecycle management.

We translate core manufacturing documents that define how pharmaceutical products are developed and produced:

  • Batch production records
  • Manufacturing protocols and instructions
  • Standard Operating Procedures (SOPs)
  • Raw material specifications and testing methods
  • Stability studies and storage condition reports

These documents are essential for demonstrating product integrity and reproducibility to regulatory authorities.

Our team translates detailed documentation used to establish and maintain product quality across manufacturing sites and markets:

  • Quality control reports
  • Analytical testing methods and validation protocols
  • Certificates of Analysis (CoAs)
  • Laboratory notebooks and technical lab reports
  • Pharmaceutical packaging and product labels

These materials are critical for GMP compliance and inspection readiness.

Sesen supports high-stakes regulatory filings by translating submission-ready documents that are central to drug approval processes:

  • Drug Master Files (DMFs)
  • Investigational New Drug (IND) applications
  • New Drug Applications (NDAs) and Abbreviated NDAs (ANDAs)
  • Common Technical Documents (CTDs) Modules 2 and 3
  • Quality Overall Summaries (QOS)

Our translations meet the stringent standards set by global agencies such as the FDA, EMA, and ICH, enabling your products to move smoothly through regulatory review.

Regulatory Standards & Best Practices

At Sesen, our CMC documentation translation services are aligned with the highest global regulatory and industry standards to support pharmaceutical companies in achieving compliance across international markets. We follow a rigorous, science-driven approach to ensure every translation meets submission and audit-readiness criteria.

We translate CMC documentation in accordance with the regulatory frameworks set by:

  • FDA (U.S. Food and Drug Administration)
  • EMA (European Medicines Agency)
  • PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
  • NMPA (National Medical Products Administration, China)

Our work is also guided by ICH (International Council for Harmonisation) guidelines, particularly ICH Q8–Q11, which govern pharmaceutical development, manufacturing, and quality systems. Sesen ensures that translated documents are technically precise, properly formatted, and aligned with region-specific submission requirements.

Pharmaceutical companies entering global markets must comply with local language requirements for CMC documentation, labeling, and patient-facing content. Sesen delivers accurate, culturally sensitive translations that meet:

  • Region-specific packaging and labeling regulations
  • Patient information leaflet and product insert standards
  • National language laws for regulatory submissions

Our native-speaking linguists understand the scientific and cultural context of each target market, ensuring translations are not only linguistically correct but also regulatory-compliant.

Sesen follows proven best practices in pharmaceutical translation to deliver consistency and accuracy at scale:

  • Implementation of controlled vocabularies and validated termbases
  • Use of project-specific glossaries and regulatory reference materials
  • Ongoing alignment with evolving global standards through continuous updates and internal training

By combining technical expertise with regulatory insight, Sesen helps clients mitigate risk, reduce time-to-approval, and maintain global compliance throughout the drug development and commercialization process.

Specialized Team of CMC Translation Experts

At Sesen, our CMC documentation translation services are delivered by a highly specialized team of linguists and subject-matter experts who bring deep scientific knowledge and regulatory fluency to every project. We combine technical accuracy with linguistic precision to meet the rigorous demands of global pharmaceutical compliance.

Our translators are not generalists—they are seasoned professionals with:

  • Advanced degrees in chemistry, biochemistry, molecular biology, or related life sciences
  • Extensive experience with pharmaceutical manufacturing workflows, formulation development, and analytical methods
  • Strong understanding of regulatory frameworks such as FDA, EMA, ICH, and local agency guidelines

This scientific background ensures the accurate rendering of complex terminology and process descriptions critical to CMC documentation.

We only work with linguists who possess:

  • Professional native-level fluency in the target language
  • Proven expertise in scientific and medical terminology, including region-specific usage
  • Cultural awareness to localize content in a way that meets both regulatory expectations and technical norms

This combination of linguistic precision and cultural alignment is essential for error-free submissions and global regulatory approval.

Sesen maintains the highest quality standards through:

  • Ongoing training programs to keep our translation teams current with regulatory updates, industry trends, and evolving terminology
  • Regular internal knowledge-sharing sessions focused on best practices for pharmaceutical translation, including CMC-specific challenges

By investing in continuous improvement, we ensure our experts remain at the forefront of life sciences translation excellence.

Our Translation Process & Workflow

Sesen follows a structured, quality-driven workflow for CMC documentation translation services to ensure regulatory accuracy, scientific consistency, and timely delivery. Our process is built around collaboration, subject-matter expertise, and proven linguistic methodologies tailored for pharmaceutical clients.

Every project begins with a detailed assessment to define the scope and requirements:

  • Review of document types, word count, and target languages
  • Identification of regulatory markets and submission timelines
  • Establishment of project milestones, turnaround times, and delivery formats

This step ensures alignment between client expectations and regulatory objectives from the outset.

We optimize all content prior to translation to ensure technical accuracy and consistency:

  • Creation and maintenance of project-specific terminology databases and approved glossaries
  • Pre-translation editing, file formatting, and content normalization for compatibility with translation tools and regulatory templates

This foundation enables consistency across complex multi-document submissions.

Our expert linguists and scientific editors collaborate closely throughout the translation process:

  • In-country linguists with subject-matter expertise perform the initial translation
  • Specialized reviewers conduct multiple rounds of QA for accuracy, terminology consistency, and regulatory compliance

All content is cross-checked against reference materials, source documents, and regulatory guidelines.

Before delivery, every project undergoes a final round of validation:

  • Technical and linguistic proofreading
  • Review for formatting accuracy in accordance with submission standards (e.g., CTD structure, labeling conventions)
  • Final validation to ensure readiness for submission to global health authorities

We provide secure, on-time delivery and remain available beyond project completion:

  • Delivery of final files in client-specified formats via secure channels
  • Ongoing support for document updates, change requests, or responses to regulatory agency feedback

At Sesen, we view translation as a strategic part of your regulatory process—not just a task. Our workflow is designed to reduce risk, accelerate submissions, and support successful global product approvals.

Quality Assurance & Data Security

At Sesen, quality and security are foundational to our CMC documentation translation services. We adhere to stringent industry standards to protect sensitive pharmaceutical data and deliver translations that meet the highest levels of regulatory and linguistic accuracy.

Our workflows are governed by internationally recognized quality management systems:

  • ISO 9001:2015 certification for overall quality assurance
  • ISO 17100 certification specifically for translation services, covering translator qualifications, process control, and traceability

We implement rigorous quality control checkpoints throughout the translation lifecycle, including multi-step review, validation, and final sign-off by subject-matter experts to ensure precision and consistency across all CMC documentation.

Protecting client data is a top priority. Sesen enforces strict confidentiality through:

  • Non-Disclosure Agreements (NDAs) with all linguists, project managers, and vendors
  • Secure file transfer protocols (SFTP, encrypted email, client portals)
  • Robust data encryption and access control policies for document storage and project environments

Our infrastructure is designed to meet the security expectations of global pharmaceutical companies and their regulatory partners.

Sesen maintains comprehensive risk mitigation protocols to safeguard project continuity and integrity:

  • Automated data backup systems and version control for all in-progress and completed files
  • Disaster recovery procedures for rapid restoration in the event of disruption
  • Defined escalation pathways for urgent issues, last-minute regulatory updates, or timeline risks

With Sesen, clients gain not only accurate translations but also the assurance of working with a secure, compliant, and quality-focused partner.

Multilingual Support & Global Reach

Sesen offers end-to-end CMC documentation translation services across all major and emerging pharmaceutical markets. With a global network of expert linguists and regulatory consultants, we deliver accurate, compliant translations in over 100 languages—empowering pharmaceutical companies to achieve faster approvals and successful product launches worldwide.

We support a broad range of languages to meet the needs of global submissions:

  • Core regulatory markets: English, Chinese, Japanese, Spanish, French, German, Russian, and more
  • Coverage of emerging markets and region-specific dialects, including Arabic, Vietnamese, Polish, Brazilian Portuguese, and others
  • Ability to align with local language requirements for regulatory filings, labeling, and patient-facing materials

All translations are performed by native-speaking linguists with life sciences expertise and deep familiarity with CMC terminology.

Global compliance demands more than accurate language—it requires local context. Sesen works with in-country experts to provide:

  • Insight into region-specific regulatory guidelines and submission standards
  • Cultural and linguistic adaptation to ensure clarity, appropriateness, and regulatory acceptance in each market
  • Elimination of ambiguities that could result in agency queries or submission delays

Our regional focus ensures your documentation resonates with both regulators and stakeholders.

Whether you’re launching a single product or managing a global pipeline, Sesen scales to meet your needs:

  • Seamless execution of high-volume, multi-language CMC projects
  • Dedicated project teams and specialized workflows for simultaneous delivery across regions
  • Agile project management designed to meet tight regulatory timelines, with built-in flexibility for last-minute updates or expedited review cycles

With our global reach and localized expertise, Sesen is equipped to support your CMC translation requirements—no matter the scope or market.

Why Choose Sesen for CMC Documentation Translation

Sesen is a trusted partner to leading pharmaceutical and biotech companies for high-stakes CMC documentation translation services. Our team brings together scientific accuracy, regulatory fluency, and multilingual expertise to ensure your CMC submissions meet global compliance standards and accelerate market approvals.

We have a strong history of supporting successful regulatory submissions across global markets:

  • On-time delivery for complex, multi-language CMC projects
  • High first-pass approval rates with agencies such as the FDA, EMA, and PMDA
  • Trusted by pharmaceutical and biotech clients for mission-critical translations, including INDs, NDAs, and DMFs

Client testimonials and case studies consistently highlight our reliability, quality, and responsiveness.

Sesen offers a full suite of pharmaceutical translation and localization services to support the entire product lifecycle:

  • Labeling translation, regulatory packaging, and marketing collateral localization
  • Integration with eCTD submission workflows, ensuring seamless regulatory readiness
  • Synergy with related Sesen offerings, including medical writing, clinical trial translation, and regulatory affairs support

This integrated approach streamlines project management and enhances consistency across documentation types.

We tailor every engagement to meet your specific needs:

  • Flexible pricing models based on document complexity, volume, and language scope
  • Value-added services, including terminology management, translation memory optimization, and post-project updates
  • Transparent quotes and scalable solutions that align with regulatory timelines and budget requirements

Sesen provides efficiency without compromising quality.

Our clients benefit from personalized service and clear communication at every stage:

  • A single point of contact ensures accountability and continuity throughout the project lifecycle
  • Responsive project management teams available to address urgent needs, answer technical questions, and coordinate across global time zones

We work as an extension of your regulatory and operations teams, delivering proactive support and peace of mind.

Related Resources

To further support your regulatory translation needs, Sesen offers a range of resources designed to streamline the CMC documentation translation process and keep you informed.

Downloadable Guides

  • CMC Translation Best Practices Checklist

    – A step-by-step guide for preparing your documents for accurate and efficient translation.

  • Top Regulatory Challenges in CMC Documentation Translation

    – Learn how to navigate common issues in global CMC submissions.
Blog & Knowledge Center

Explore articles on:

  • Industry updates and global regulatory trends
  • CMC translation workflows, terminology management, and localization strategy
  • Lessons from real-world pharmaceutical translation projects
FAQ

Your Questions Answered

Turnaround times vary based on document volume, complexity, and number of target languages. Most CMC translation projects are completed within 3–5 business days, with expedited service available for urgent regulatory timelines.

Pricing is based on several factors, including word count, language pair(s), technical complexity, and formatting requirements. We offer flexible, per-word pricing models and provide transparent quotes before project launch.

All translations are performed by native-speaking linguists with advanced degrees in chemistry, biochemistry, or related life sciences. Each linguist is experienced in pharmaceutical regulatory content and undergoes regular training on industry standards and agency guidelines.

Sesen enforces strict data privacy protocols, including NDA agreements, encrypted file transfer, secure cloud infrastructure, and access-controlled environments. Your CMC documentation is handled with the highest level of confidentiality and regulatory compliance.

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