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pharmaceutical-manufacturing-translation

Why Translation Matters in Pharmaceutical Manufacturing

Pharmaceutical manufacturing translation plays a vital role in ensuring the accuracy, consistency, and regulatory compliance of documentation across global operations. As pharmaceutical companies expand production and sourcing across borders, the need for precise multilingual communication increases.

Manufacturing workflows involve complex documentation, including standard operating procedures (SOPs), batch records, quality control protocols, and equipment validation reports. Errors or inconsistencies in translated content can disrupt production processes, lead to failed audits, or result in regulatory penalties. GMP translation services are essential for maintaining Good Manufacturing Practice compliance and supporting successful inspections by regulatory bodies such as the FDA, EMA, and PMDA.

The global nature of pharmaceutical supply chains adds another layer of complexity. Materials and components often come from multiple countries, requiring seamless coordination across teams speaking different languages. Accurate translation ensures that every stakeholder, from local operators to international auditors, works from the same high-quality documentation.

Sesen’s pharmaceutical manufacturing translation services help life sciences companies eliminate language barriers, reduce compliance risks, and maintain operational continuity across markets.

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Manufacturing Documents We Translate

Sesen supports accurate and compliant pharmaceutical manufacturing translation across a wide range of regulated documents. Our translations are optimized for batch manufacturing record translation, validation protocol translation, and global GMP alignment.

Detailed instructions for routine processes, translated to maintain procedural integrity across global facilities. See SOP Translation Services »

Comprehensive documentation of each production run, essential for traceability, product release, and regulatory review.

Authoritative formulation and manufacturing instructions required before batch initiation, aligned with regulatory expectations.

Qualification documents verifying equipment installation, operational performance, and process consistency.

Technical documentation of process optimization, scale-up, and reproducibility during development and tech transfer.

Structured materials used to transition processes from R&D to manufacturing sites or contract development organizations.

Step-by-step cleaning instructions and validation logs for maintaining sterile environments and avoiding cross-contamination.

Records of microbial and particulate monitoring data used to validate cleanroom performance and aseptic controls.

Manufacturer specifications and internal calibration records that support GMP equipment qualification and audit readiness.

Multilingual documents specifying packaging formats, label content, and country-specific compliance, often translated in parallel with our drug labeling and packaging translation services.

Corrective action documentation and deviation analyses that support continuous improvement and GMP inspection responses.

Source documentation detailing identity, quality attributes, and testing requirements for input materials.

Risk assessment documents created under ICH Q9, covering potential failures and mitigation plans in manufacturing.

Translated responses, reports, and records prepared for regulatory audits and third-party inspections.

Translation Expertise Across Manufacturing Modalities

Sesen provides specialized pharmaceutical manufacturing translation services across a wide range of production modalities. Our translators are trained in both the scientific terminology and process-specific documentation requirements that support GMP compliance, quality assurance, and regulatory readiness. We deliver high-accuracy translations tailored to the distinct needs of each manufacturing model, from early-stage production to commercial scale.

Translation support for API manufacturing, chemical synthesis, granulation, coating, and tableting processes. Our expertise covers process chemistry documentation, analytical method validation, and production batch records.

Accurate translation of documents for upstream cell culture, downstream purification, sterile filtration, and bulk filling. Sesen’s biologics manufacturing translation services support monoclonal antibody production, biosimilars, and recombinant proteins.

Specialized translations for autologous and allogeneic workflows, including patient-specific labeling, chain-of-identity forms, and traceability documentation required by regulators.

Multilingual translation of clinical-grade and commercial vaccine production protocols, adjuvant preparation, fill-finish operations, and WHO Prequalification (PQS) documentation.

Language services that facilitate clear communication between sponsors and CDMO or CMO partners. We translate tech transfer documents, quality agreements, and production change controls.

End-to-end translation of API development documentation, from reaction pathway design and process optimization to GMP analytical reports and impurity profiling.

Support for sterile manufacturing environments including gowning procedures, cleanroom protocols, and aseptic fill-finish instructions to maintain product integrity.

Translation of real-time process control documentation, PAT (process analytical technology) protocols, and adaptive manufacturing system files.

Accurate multilingual support for temperature-controlled shipping workflows, distribution records, and GDP (Good Distribution Practice) documentation.

Sesen’s expertise across these manufacturing areas ensures consistency, accuracy, and regulatory alignment throughout the global pharmaceutical production lifecycle.

Regulatory Compliance Across Global GMP Frameworks

Sesen’s pharmaceutical manufacturing translation services are designed to meet the rigorous standards set by global regulatory authorities. Our translations are prepared with full awareness of the technical terminology, structural formatting, and quality expectations required to support compliant manufacturing and regulatory audits. We work closely with clients to ensure all translated content aligns with regional and international Good Manufacturing Practice (GMP) frameworks.

Translations support U.S. GMP regulations for drug manufacturing, processing, and packaging. This includes master records, control procedures, labeling operations, and quality assurance documentation.

We translate manufacturing documents in compliance with EMA’s detailed guidance for human and veterinary medicinal products. This includes sterile processing protocols, QP declarations, and facility qualification records.

Our translations reflect the standards outlined in ICH guidelines for API manufacturing (Q7), pharmaceutical development (Q8), and pharmaceutical quality systems (Q10). This ensures harmonization across global supply chains and supports regulatory submission translation for regional and international filings.

Translation of documentation for facilities seeking compliance with WHO-prequalified product requirements. Includes multi-site production protocols, GMP inspection responses, and product release documentation.

Accurate translations prepared for Japanese GMP audits and regulatory submissions. This includes documents required by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

Sesen supports local regulatory alignment for markets including Brazil (ANVISA), Canada (Health Canada), China (NMPA), and Saudi Arabia (SFDA). We adapt terminology and formatting based on country-specific documentation rules and linguistic standards.

By aligning with these global frameworks, Sesen helps pharmaceutical companies prepare accurate, audit-ready documentation that facilitates product approval, inspection readiness, and international market access.

Quality Assurance and Terminology Management

Sesen maintains the highest standards of linguistic precision and regulatory accuracy through a rigorous quality assurance process tailored for pharmaceutical manufacturing translation. Our approach ensures that all translated materials meet the expectations of both global regulatory bodies and internal quality systems.

We apply validated life sciences glossaries, controlled vocabularies, and client-approved style guides to promote consistency and clarity across all manufacturing documents. Our terminology management tools preserve critical language for processes such as API manufacturing, batch release, and GMP documentation.

All projects follow certified translation workflows that meet the requirements of:

  • ISO 17100 for translation services quality
  • ISO 9001:2015 for quality management systems
  • ISO 13485:2016 for medical device and life sciences documentation

Sesen’s linguists possess specialized subject matter expertise in pharmaceutical manufacturing, including biologics production, sterile processing, and validation reporting. We assign linguists with relevant scientific backgrounds and language fluency to each project.

Our multi-step quality control process includes:

  • Initial translation by qualified experts
  • Independent linguistic review for accuracy and fluency
  • Technical review to ensure terminology and formatting compliance
  • Final regulatory review to confirm readiness for audits or submissions

This structured QA approach allows Sesen to deliver manufacturing translations that reduce compliance risk and complement our quality assurance and audit support translation services.

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Secure and Scalable Translation Workflows

Sesen provides pharmaceutical manufacturing translation services built for scalability, consistency, and data security. Our workflows are designed to handle high-volume multilingual projects across diverse manufacturing documentation types while ensuring compliance with data protection standards.

We support large-scale translation across multiple language pairs, enabling pharmaceutical companies to operate seamlessly in global markets. Whether translating SOPs, validation protocols, or batch manufacturing records, our infrastructure can accommodate complex production timelines and high content throughput.

To maintain consistency across documents and projects, Sesen employs translation memory (TM) and version control systems. These tools preserve previously approved terminology and phrasing, reduce turnaround times, and help ensure alignment across all updates and revisions.

Our translation workflows integrate with client-side platforms such as:

  • Learning Management Systems (LMS)
  • Quality Management Systems (QMS)
  • Electronic Document Management Systems (eDMS)

This allows for secure, automated file exchange and seamless integration into existing document control processes.

Sesen also prioritizes confidentiality and data security. All documents are handled in encrypted environments, with access restricted to authorized personnel. We adhere to strict internal protocols and client-specific requirements to safeguard proprietary manufacturing data and intellectual property.

These scalable and secure processes ensure that Sesen can deliver compliant, high-quality translations for pharmaceutical manufacturing at every stage of production and distribution.

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Related Services

Sesen offers a full suite of life sciences translation services that complement pharmaceutical manufacturing workflows. Our integrated language solutions support quality, compliance, and global market readiness across regulated environments.

Precise translation of standard operating procedures that govern manufacturing practices, equipment use, and safety protocols. Designed to meet GMP documentation requirements and withstand regulatory inspections. To learn more about our SOP translation solutions for life sciences, please click here.

Language support for dossiers, Module 3 content, and chemistry, manufacturing, and controls (CMC) documentation required by regulatory bodies such as the FDA, EMA, and PMDA.

Multilingual translation of product labels, inserts, cartons, and packaging artwork for global distribution. Services include in-context QA and compliance with regional labeling regulations.

Translation of CAPA reports, deviation logs, audit responses, and internal QA documentation to support inspection readiness and continuous improvement processes.

Localization of manufacturing software systems including MES, LIMS, and SCADA (Supervisory Control and Data Acquisition) platforms through our clinical and medical software localization services for GMP-regulated environments.

These services are designed to work seamlessly with our pharmaceutical manufacturing translation solutions, enabling end-to-end language support across your product lifecycle.

Why Sesen

Sesen is a trusted partner for pharmaceutical manufacturing translation services, delivering high-accuracy, regulatory-compliant translations across global production environments. Our deep expertise in life sciences and commitment to quality make us the preferred language provider for pharmaceutical, biotech, and CDMO organizations.

We understand the documentation needs of pharmaceutical manufacturing, including GMP protocols, validation reporting, batch records, and tech transfer files. Our linguists and project managers are experienced in translating process-critical documents for small molecule, biologics, and advanced therapy production.

Sesen supports leading pharmaceutical and biotech companies, as well as contract manufacturing organizations, with tailored translation solutions. Our clients rely on us for high-stakes documentation required for product approval, regulatory audits, and global distribution.

Our workflow infrastructure supports rapid delivery of large-volume multilingual content. Whether for product launches, facility inspections, or global expansion, we offer the scale and agility to meet tight timelines without compromising quality.

We work exclusively with native-speaking linguists who are trained in pharmaceutical terminology and manufacturing processes. With support for more than 150 languages, Sesen ensures linguistically accurate and scientifically precise translations across all target markets.

Sesen brings together technical accuracy, regulatory insight, and scalable execution to help life sciences companies operate confidently across global manufacturing landscapes.

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