Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.

No, thanks

BOOK A MEETING BOOK A MEETING
   
Sign In
modular-submission-translation-content-reuse

Smarter Global Submissions with Modular Translation & Reuse

In today’s highly regulated life sciences environment, pharmaceutical, biotechnology, and medical device companies must deliver multilingual regulatory content with speed, accuracy, and global consistency. As health authorities increasingly mandate structured submission formats—such as IDMP (Identification of Medicinal Products), SPL (Structured Product Labeling), and XML-based dossiers—the demand for modular submission translation and intelligent content reuse has become critical.

Sesen provides specialized translation solutions tailored to component-based content workflows, enabling clients to author once and reuse across markets and languages. Our modular approach streamlines translation for recurring data elements such as dosage forms, indications, and safety information, ensuring alignment across submission types and reducing time-to-market. By combining regulatory expertise with XML-aware tools and structured content processes, Sesen supports global compliance and content integrity at scale.

Understanding Modular Submissions in Life Sciences

Modular submission refers to the creation and management of regulatory content as discrete, reusable components rather than as static, linear documents. Unlike traditional submissions—where each dossier is treated as a standalone file—modular submissions break down key product information (e.g., indications, safety data, dosage forms) into structured content blocks that can be reused across different submissions, languages, and jurisdictions.

This approach is especially critical for maintaining compliance with evolving global regulatory requirements from authorities such as the EMA, FDA, PMDA, and Health Canada, which increasingly favor structured, electronic submission formats. Modular content strategies align with frameworks such as IDMP (Identification of Medicinal Products) and SPL (Structured Product Labeling), both of which rely on consistency, interoperability, and data integrity.

At the core of modular submissions is the use of XML-based structured authoring, which enables standardized tagging, easier updates, and seamless integration with content management systems. This structured approach ensures that each content module can be efficiently translated, validated, and reused—reducing duplication, improving quality, and accelerating global approvals.

Read More Read Less

Key Benefits of Content Reuse in Regulatory Translation

At Sesen, content reuse is central to enabling faster, more consistent, and cost-effective regulatory translations for global life sciences companies. By leveraging previously translated and approved content components, our modular approach helps streamline multilingual submissions while supporting compliance with international regulatory standards.

Reusing validated content eliminates the need to retranslate identical components across documents, significantly reducing localization timelines and expediting global product launches.

Standardizing reusable content ensures terminological and stylistic consistency across regulatory dossiers, patient-facing materials, and product labeling—minimizing the risk of discrepancies and audit findings.

Content reuse supports structured submission standards such as ISO IDMP, HL7 SPL, and eCTD, where precise alignment of data elements is essential for regulatory acceptance and lifecycle management.

Translating content modules once and reusing them across multiple files and markets lowers overall translation costs, reduces resource strain, and maximizes ROI.

Modular translation enables seamless reuse of language assets across different countries and regulatory agencies, supporting efficient localization of drug labels, IFUs, safety updates, and more.

Component-Based Translation Workflows for Structured Regulatory Content

Component-based translation—also known as modular translation—is a structured approach that treats content as discrete, reusable modules rather than as monolithic documents. This methodology is essential for supporting global regulatory submissions that require consistent, updatable, and format-compliant documentation.

Component-based translation breaks down content into standalone units such as dosage instructions, safety information, indications, and administration routes. These modules are translated independently and reused across multiple submission formats and markets, ensuring consistency and scalability.

This approach is particularly effective for XML-based regulatory documents, including SPL (Structured Product Labeling), IDMP-compliant submissions, and structured leaflets. XML allows for precise tagging and segmentation, enabling modular translation workflows that align with international regulatory standards.

Modules typically include high-frequency elements such as adverse events, contraindications, product descriptions, storage conditions, and dosage forms. Reusing these modules across products and regions improves both translation efficiency and regulatory alignment.

Sesen integrates seamlessly with structured content authoring systems, including XML editors and Component Content Management Systems (CCMS). This enables real-time content reuse, version control, and collaborative updates between regulatory, medical writing, and localization teams—reducing manual errors and ensuring submission-ready outputs.

Sesen delivers specialized modular translation solutions purpose-built for the life sciences industry, supporting structured regulatory submissions across global markets. Our capabilities are designed to integrate seamlessly with modern content ecosystems and uphold the highest standards of quality, consistency, and compliance.

Integration with Structured Content Management Systems

We work with leading Component Content Management Systems (CCMS) and structured authoring platforms to support content modularization, translation automation, and real-time updates. Our workflows ensure that translated modules are aligned with authoring environments for efficient reuse and easy deployment across regulatory documents.

Sesen uses XML-aware CAT tools and employs linguists trained in handling structured content formats such as SPL and IDMP. This ensures that critical tags, data structures, and schema requirements are preserved throughout the translation process.

Our workflows are powered by robust translation memory (TM) systems that store and retrieve previously translated segments for reuse. This not only accelerates turnaround times but also ensures consistency across recurring content such as dosage, safety warnings, and indications. TM integration helps reduce costs and supports regulatory compliance by aligning with approved and validated content.

We implement rigorous quality assurance protocols, including automated validation tools and format-specific checklists, to ensure all translated content meets regulatory schema and content validation rules for IDMP, SPL, and other structured formats.

Sesen maintains centralized, domain-specific glossaries and client-approved style guides to promote consistent terminology and voice across content modules. These resources are embedded into our translation workflows to enhance quality and streamline updates.

Our modular workflows include granular change tracking and version control at the component level. This enables traceable updates, simplifies regulatory revisions, and reduces translation duplication—improving efficiency while maintaining submission integrity.

Supported Formats & Technologies

Sesen’s modular translation solutions are fully aligned with global regulatory requirements and support the full spectrum of structured submission formats used in life sciences. Our workflows are designed to integrate with industry-standard content models and enable seamless localization of data-driven regulatory documentation.

We support translation and localization of IDMP-aligned content, including structured data submissions for EMA’s SPOR and XEVMPD systems. Our workflows accommodate ISO 11615 and ISO 11616 data models, ensuring accurate representation of product, substance, and organization data across languages and jurisdictions.

Sesen provides XML-aware translation of Structured Product Labeling documents for FDA submissions. Our linguists and tools preserve schema integrity while accurately localizing dosage, indications, warnings, and patient information, ensuring full compliance with HL7 SPL standards.

We support both electronic Common Technical Document (eCTD) and Non-eCTD electronic Submission (NeeS) formats used across global regulatory bodies. Our structured content workflows enable localization of module-based submissions with precise control over regional variations and lifecycle updates.

Sesen’s modular translation process integrates with major regulatory publishing platforms and CCMS solutions, allowing for real-time content synchronization, reuse, and streamlined submission preparation. This ensures seamless delivery of compliant, multilingual content across submission types.

Our translation technology and processes are fully compatible with global data standards such as HL7 (Health Level Seven) for structured healthcare content and ISO 11615/11616 for medicinal product and substance data. This enables reliable translation of structured datasets in compliance with international regulatory frameworks.

Why Choose Sesen for Modular Submission Translation?

Sesen is a trusted partner for life sciences companies seeking high-quality, scalable, and compliant modular translation solutions. Our deep industry expertise, structured content capabilities, and commitment to regulatory precision position us as a leader in supporting global submission workflows.

Our exclusive focus on the life sciences sector enables us to deliver specialized translation solutions for pharmaceutical, biotechnology, and medical device companies—ensuring relevance, accuracy, and regulatory alignment across all content types.

We support modular submissions tailored to the requirements of global regulatory authorities, including the FDA, EMA, PMDA, and Health Canada. Our teams are well-versed in IDMP, SPL, eCTD, and other region-specific formats to ensure international compliance.

Sesen assigns experienced project managers with in-depth knowledge of structured content, XML schema requirements, and IDMP frameworks. They coordinate each phase of the modular translation process to ensure precision, efficiency, and smooth integration with client systems.

Our modular workflows combine advanced translation technology—including XML-aware CAT tools and translation memory systems—with the subject matter expertise of professional linguists. This hybrid model ensures consistent, high-quality output while enabling efficient content reuse.

Sesen adheres to rigorous quality and compliance standards, including ISO 17100 for translation services, ISO 9001 for quality management, and ISO 13485 for medical device translation. These certifications reflect our commitment to delivering accurate, validated translations that meet regulatory and industry benchmarks.

Case Study: Reducing Global Labeling Timelines with Modular Translation

A leading pharmaceutical client partnered with Sesen to streamline the translation of global labeling content for a portfolio of combination drug-device products. Facing increasing pressure to accelerate multilingual submissions while maintaining regulatory accuracy, the client implemented a modular content strategy built on structured authoring and intelligent content reuse.

Sesen deployed a component-based translation workflow that aligned with the client’s XML content architecture and regulatory publishing systems. By segmenting reusable content modules—such as indications, dosage instructions, and safety statements—and leveraging translation memory across languages, we were able to reduce duplication and accelerate approval timelines.

Results:

  • 40% reduction in overall global labeling translation timelines
  • Significant cost savings due to reuse of validated components
  • Improved regulatory consistency across EU, U.S., and APAC submissions
  • Streamlined updates using version-controlled content blocks

Related Services

Sesen’s modular translation solutions are part of a broader suite of regulatory and labeling localization services tailored to the life sciences industry. Explore our related offerings that enhance consistency, compliance, and efficiency across your global content lifecycle:

Ensure accurate, region-specific translations of product labels, cartons, and leaflets to meet regulatory requirements and enhance patient safety. Explore our full offering for Drug Labeling & Packaging Translation.

Deliver multilingual, compliant IFUs for medical devices in accordance with MDR and IVDR guidelines. Learn more about our IFU Translation Services.

Establish consistent terminology and voice across documents to improve content reuse and ensure alignment with regulatory expectations. View our approach to Glossaries & Style Guides.

Leverage AI to automate terminology extraction, alignment, and updates across structured content environments. See how we support intelligent reuse with AI for Terminology Management.

Access comprehensive translation solutions for global regulatory submissions, including IDMP, SPL, and eCTD formats. Explore our Regulatory Translation Services for life sciences.

Get in Touch

Ready to streamline your global regulatory submissions with modular translation and content reuse?

Contact Sesen to schedule a consultation or request a customized quote. Our team is here to help you implement structured, scalable solutions tailored to IDMP, SPL, and XML-based workflows.

REQUEST A QUOTE REQUEST A QUOTE
CONTACT US CONTACT US