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Accurate GMP Translations to Support Global Compliance

Good Manufacturing Practice (GMP) refers to the systems and processes required to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. GMP regulations are enforced by agencies such as the FDA, EMA, and other global health authorities to safeguard product safety, identity, strength, quality, and purity.

Accurate GMP translation is essential for companies operating across international borders. Whether translating commercial batch records from Finnish to English, standard operating procedures (SOPs) for global teams, or quality assurance documentation for regulatory inspections, precision and consistency are critical. Errors or omissions in translated GMP documents can lead to compliance issues, regulatory delays, or even product recalls.

At Sesen, we combine subject matter expertise, ISO-certified workflows, and deep industry knowledge to deliver high-quality GMP translations that meet the stringent requirements of life sciences clients. Our linguists are trained in GMP terminology and experienced in translating technical documentation for regulatory and manufacturing contexts.

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Why GMP Translation Matters

Accurate translation of GMP documentation is essential for maintaining compliance with regulatory authorities such as the FDA, EMA, PMDA, and other global agencies. During audits and inspections, translated batch records, SOPs, and quality reports must reflect the original content precisely to ensure product traceability and manufacturing integrity.

As pharmaceutical and biotech companies increasingly operate across borders, the ability to provide translated GMP documentation for product release in multiple markets has become a regulatory necessity. Manufacturing activities conducted at foreign sites often require English translations of original-language records to facilitate timely review by global quality teams and regulatory bodies.

Poorly translated GMP documents can result in audit findings, delayed product approvals, or rejected manufacturing lots. Investing in expert translation helps mitigate compliance risks, supports consistent quality across production sites, and ensures that critical documentation stands up to regulatory scrutiny. Sesen provides life sciences companies with the linguistic precision and quality assurance required to meet the highest GMP standards worldwide.

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GMP Documents We Translate

Sesen provides expert translation of GMP documentation to help life sciences companies meet global regulatory expectations. Below are the key document types we support, each translated by subject matter linguists with life sciences and manufacturing expertise.

Translation of manufacturing and packaging batch records to support lot release, traceability, and compliance with regulatory inspection requirements. Includes production steps, in-process controls, and deviation notes.

Precise translations of SOPs to ensure consistent execution of processes across international sites. Covers manufacturing, cleaning, quality control, and safety protocols.

Translation of QA records such as deviations, CAPAs, audit findings, and quality control test reports. Supports internal QA teams, external audits, and global quality system integration.

Accurate translations of COAs for raw materials, active pharmaceutical ingredients (APIs), intermediates, and finished products. Ensures proper documentation for product release and regulatory filing.

Translation of detailed manufacturing process documents including master batch records, process flow diagrams, and validation protocols for both clinical and commercial production.

Covers cleaning validation reports, equipment use logs, and maintenance records to demonstrate GMP-compliant facility and equipment management practices.

Translation of GMP-related content included in regulatory dossiers, such as Module 3 of the Common Technical Document (CTD), used for submissions to FDA, EMA, and other global agencies.

Industries and Clients We Support

Sesen provides GMP translation services to a broad range of life sciences organizations involved in regulated manufacturing and quality operations. Our clients rely on us for linguistically accurate, audit-ready translations that align with global regulatory standards.

Support for both branded and generic drug manufacturers translating batch records, SOPs, and QA documentation for global production and regulatory filings.

Specialized translation services for early-stage and commercial biotech firms requiring GMP-compliant documentation across clinical and manufacturing operations.

Contract Development and Manufacturing Organizations working with multinational sponsors depend on Sesen to translate GMP documents that ensure consistency, traceability, and compliance across client portfolios.

Translation of COAs, master batch records, and process documentation for active pharmaceutical ingredient manufacturers supplying regulated markets.

GMP-related translation support for medical device manufacturers governed by ISO 13485 and regional quality regulations, including cleaning validation, maintenance logs, and production protocols.

Our industry-aligned workflows ensure that every translation is handled by linguists with domain expertise, supported by ISO-certified quality assurance processes.

Our Process for GMP Translation Projects

Sesen follows a structured and quality-driven approach to ensure every GMP translation meets the highest standards for accuracy, consistency, and regulatory compliance.

We begin by defining project scope, file types, and deadlines. Our team collaborates with clients to identify product- and process-specific terminology, creating custom glossaries and style guides to maintain consistency across all translated materials.

Translations are performed by native-speaking linguists with deep knowledge of GMP-regulated manufacturing processes. Each linguist is selected based on expertise in pharmaceutical, biotech, or device production to ensure accurate handling of technical content.

All translations undergo a multi-step review process in accordance with ISO 17100, ISO 9001, and ISO 13485 standards. This includes bilingual proofreading, terminology verification, and structured quality control checks before delivery.

Final files are delivered in the required format, ready for submission to global regulatory authorities or use in GMP audits. We ensure all content meets client specifications and supports compliance with FDA, EMA, and international requirements.

This end-to-end workflow allows Sesen to deliver GMP translations that meet both linguistic and regulatory expectations.

Languages Supported

Sesen delivers GMP translation services in over 150 languages, supporting global manufacturing and regulatory operations across all major markets. Whether translating commercial batch records from Finnish, SOPs from Japanese, or QA documentation from German or Chinese, our linguistic network ensures precise, context-aware translations tailored to GMP environments.

Our team includes bilingual project managers who oversee complex multilingual workflows and serve as the primary point of contact for coordinating terminology, timelines, and quality checks across language pairs. This ensures seamless communication, efficient project execution, and consistent output across large-scale, multi-country GMP documentation projects.

Sesen is equipped to support both single-language requests and high-volume, multilingual translation programs for pharmaceutical, biotech, and device clients operating globally.

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Optimized GMP Translation Workflows

Sesen combines advanced linguistic technologies with expert human oversight to ensure consistency, accuracy, and regulatory alignment in every GMP translation project. We utilize translation memory (TM) systems and terminology management tools to maintain uniformity across recurring phrases, technical terms, and document sets—essential for large-scale or ongoing GMP translation workflows.

For clients that allow machine translation under strict quality controls, we offer hybrid workflows using Machine Translation Post-Editing (MTPE). These workflows are led by trained linguists with GMP subject matter expertise and follow the same ISO-certified QA steps as our fully human translation processes.

This integrated approach allows us to accelerate turnaround times, reduce costs, and maintain the high level of precision required for regulatory and audit-facing GMP documentation.

Why Sesen

Sesen is a trusted partner for GMP translation services, backed by over 15 years of experience serving pharmaceutical, biotechnology, and medical device companies operating in regulated environments. Our deep expertise in translating GMP-critical documents, including commercial batch records, SOPs, and quality assurance reports, has helped clients meet global regulatory expectations with confidence.

We are certified under ISO 17100, ISO 9001:2015, and ISO 13485:2016, reflecting our commitment to quality, consistency, and risk-managed translation processes tailored to the life sciences sector.

Every project is managed by a dedicated team with domain-specific knowledge, including project managers who understand GMP workflows and regulatory requirements. From glossary development to final delivery, we align every step of the translation process with your internal QA systems and international compliance needs.

Partnering with Sesen means working with a language solutions provider that understands the technical, linguistic, and regulatory complexity of GMP documentation.

Client Use Cases

Sesen has supported GMP-regulated organizations around the world with high-quality translation solutions tailored to inspection readiness, product release, and global compliance. Below are representative examples of recent engagements:

  • Translated commercial batch records from Finnish to English for a clinical-stage biopharmaceutical company preparing for an FDA inspection of its EU-based manufacturing facility.
  • Localized SOPs and QA documentation for a U.S.-based generic drug manufacturer expanding production to Southeast Asia and undergoing concurrent audits by local and international regulators.
  • Provided multilingual GMP translation support for a global CDMO managing product transfers across sites in Germany, Japan, and Canada, ensuring consistency across COAs, equipment logs, and validation protocols.
  • Delivered fast-turnaround translations of deviation reports and CAPAs for a vaccine manufacturer responding to a regulatory audit in real time.

These case studies demonstrate Sesen’s ability to deliver precise, compliant translations under tight timelines and complex project scopes, helping clients navigate global GMP expectations with confidence.

Frequently Asked Questions

Yes. Sesen provides certified translations upon request to support regulatory submissions, audits, and compliance reviews. Our certifications include translator declarations, project metadata, and company credentials in line with agency expectations.

We regularly handle expedited GMP translation projects for clients facing inspection deadlines or urgent product release requirements. Our global team enables rapid resource allocation while maintaining quality through ISO-certified workflows.

Sesen follows strict data security protocols, including NDA agreements, secure file transfer systems, and role-based access controls. All linguists and project managers are trained on confidentiality requirements and industry-specific data handling policies.

We support a wide range of file formats including PDF, Word, Excel, scanned documents, and structured templates exported from QMS and LIMS platforms. Our team can process both editable and non-editable formats while preserving layout integrity where needed.

Related Services

Sesen offers a full range of specialized translation services that support regulatory compliance, manufacturing operations, and product lifecycle management. Explore related solutions tailored to the needs of GMP-regulated organizations.

  • Regulatory Submission Translation

    Accurate translation of CTD modules, labeling, and compliance documents for FDA, EMA, and global health authorities.Quality and Manufacturing Document Translation

    Translation of validation protocols, audit reports, and deviation records supporting GMP and QMS compliance.

  • SOP and Training Material Translation

    Localized SOPs, work instructions, and eLearning modules for GMP-compliant training programs across regions.

  • Certificates of Analysis (COA) Translation

    Precise COA translations for raw materials, intermediates, and finished products used in regulated supply chains.

  • Labeling and Packaging Translation

    Regulatory-compliant translation of carton labels, IFUs, and packaging inserts for pharmaceutical and medical products.

Ensure Your GMP Documentation Is Compliant and Translation-Ready

Work with Sesen to translate your GMP documents with precision, speed, and regulatory confidence. Our ISO-certified processes and expert linguists help you meet global compliance requirements in over 150

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