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regulatory-submission-formatting

Precision Formatting for Global Regulatory Compliance

In today’s highly regulated life sciences industry, precise formatting of multilingual regulatory submissions is critical to achieving global market approvals. Health authorities such as the FDA, EMA, PMDA, and NMPA require submissions to follow strict structural and formatting guidelines to ensure efficient review and compliance. Poorly formatted documents can lead to costly delays, rejections, and additional regulatory scrutiny.

At Sesen, we combine expert life sciences translation with compliant document formatting to deliver regulator-ready submissions across all global markets. Our specialized team supports pharmaceutical companies, biotechnology firms, medical device manufacturers, and CROs with multilingual regulatory submission formatting services that meet the highest industry standards. Whether you need eCTD formatting, NeeS preparation, or paper-based submission support, Sesen ensures your translated materials are formatted accurately, professionally, and in full alignment with agency requirements.

What Is Regulatory Submission Formatting?

Regulatory submission formatting is the specialized process of preparing translated documents to meet the stringent structural and formatting requirements set by global health authorities, including the FDA, EMA, PMDA, NMPA, and Health Canada. Unlike general document formatting, regulatory-specific desktop publishing (DTP) requires strict adherence to submission standards, including document organization, font usage, section numbering, pagination, table of contents generation, hyperlinking, and file optimization for electronic submission formats such as eCTD and NeeS.

In regulatory submission formatting, linguistic accuracy must be seamlessly integrated with technical precision. Even minor formatting inconsistencies can trigger agency feedback, slow down approval timelines, or result in rejected submissions. At Sesen, we ensure that every translated document is formatted to meet both the linguistic and technical standards necessary for global regulatory acceptance, providing life sciences companies with submission-ready documentation across all major markets.

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Why Multilingual Regulatory Formatting Matters

In today’s globalized life sciences market, multilingual regulatory submissions are essential for securing product approvals across multiple countries and regions. Each regulatory authority—from the FDA and EMA to PMDA and NMPA—imposes specific requirements for how documents must be structured, formatted, and presented. These standards cover critical details such as page layout, font type, margin settings, section numbering, header hierarchy, and file organization for electronic submissions like eCTD and NeeS.

Accurate translation alone is not enough. Localized documents must be precisely formatted to align with each regulator’s technical specifications. Even minor formatting discrepancies, such as misaligned sections or incorrect pagination, can lead to agency requests for corrections, submission delays, or outright rejection.

At Sesen, we understand that multilingual regulatory submission formatting is not just about presentation—it is a critical step in achieving timely global approvals. Our expertise ensures that your translated documents meet the highest regulatory expectations, minimizing risks and accelerating your path to market.

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Our Multilingual Regulatory Submission Formatting Services

Sesen provides end-to-end multilingual formatting solutions to support life sciences companies in preparing fully compliant regulatory submissions. Our services combine expert translation with technical document formatting to meet country-specific agency requirements for pharmaceuticals, biotechnology, medical devices, and clinical research organizations. Whether you need complete eCTD package preparation or precise formatting for standalone documents, we deliver regulator-ready materials in over 150 languages.

We format a wide range of critical regulatory documents to agency specifications, including:

  • Clinical Study Reports (CSRs) – Structured and paginated for seamless inclusion in CTD submissions.
  • Investigator’s Brochures (IBs) – Aligned with ICH E6 (R2) requirements for clinical trial documentation.
  • Patient Informed Consent Forms (ICFs) – Formatted for both regulatory approval and patient readability.
  • Common Technical Document (CTD) Modules – Properly formatted across Modules 1–5, supporting both regional and international standards.
  • Risk Management Plans (RMPs) – Structured to meet EMA and FDA regulatory requirements.
  • Regulatory Briefing Books – Professionally organized for agency review meetings and milestone submissions.
  • Instructions for Use (IFUs) for Medical Devices – Formatted to comply with MDR, IVDR, and FDA device labeling guidelines.
  • Regulatory Meeting Materials – Including presentation slides and handouts, formatted for formal submission and agency engagement.

Our multilingual formatting services cover all major submission types, ensuring your documents are technically compliant and submission-ready:

  • eCTD (electronic Common Technical Document) Formatting
    Preparation of compliant eCTD files, including document granularity, hyperlinking, and section numbering, fully aligned with ICH and regional specifications.
  • NeeS (Non-eCTD Electronic Submissions)
    Properly formatted PDFs optimized for electronic-only submissions where eCTD is not mandated.
  • Paper Submission Formatting
    Full formatting services for hard-copy submissions, including print-ready layouts, consistent pagination, and agency-specific presentation requirements.
  • PDF Optimization and Bookmarking for Submission Packages
    Secure, searchable PDFs with correct bookmarking, hyperlinking, and metadata to facilitate electronic review by regulatory authorities.

How We Ensure Compliance and Accuracy

At Sesen, we apply a rigorous, multi-layered quality assurance process to deliver multilingual regulatory submission documents that meet the highest standards of global compliance. Our approach combines deep regulatory expertise, advanced linguistic validation, and technical formatting precision, ensuring that every document is submission-ready, agency-compliant, and linguistically accurate. We take every measure to minimize risks and support faster regulatory approvals for our clients across life sciences sectors.

Our formatting processes are firmly aligned with international regulatory guidelines, including:

  • ICH (International Council for Harmonisation) Requirements – Ensuring consistent module structure and document granularity.
  • FDA, EMA, PMDA, Health Canada, and NMPA Standards – Adapting formatting to each authority’s specific electronic and paper submission expectations.
  • Agency-Specific Preferences – Incorporating nuances such as Health Canada’s bilingual presentation requirements or FDA’s style preferences for labels, headings, and pagination to optimize agency review and approval.

Our regulatory experts stay current with evolving submission guidelines to ensure your documents remain compliant with the latest regional and global standards.

After formatting, all multilingual submissions undergo comprehensive validation steps to guarantee linguistic and technical accuracy:

  • Bilingual/Multilingual Review – Native-speaking regulatory translators review the formatted documents to confirm that content integrity, terminology consistency, and linguistic nuances are preserved.
  • Final QA Checks – Our quality assurance specialists verify layout fidelity, cross-referencing, file metadata, and document navigation elements such as hyperlinks and bookmarks to ensure full submission-readiness.

These combined linguistic and technical validations are crucial to preventing errors that could result in costly rework or submission delays.

To ensure flawless delivery, Sesen applies a proven, multi-step quality control process throughout the formatting workflow:

  • Pre-DTP Quality Assurance – Initial assessment of source and translated files for completeness, structural integrity, and regulatory-specific formatting needs.
  • Formatting QA – Ongoing verification during document formatting to maintain compliance with agency specifications, page numbering, table structuring, and template consistency.
  • Post-DTP Linguistic Review – Final linguistic and technical review to validate that formatting changes have not introduced errors and that all cross-links, annex references, and tables of contents are accurate and functional.

Our rigorous quality methodology ensures that every submission package is technically sound, regulator-ready, and globally compliant.

Technology and Tools We Use

Sesen leverages industry-leading technologies and secure workflows to deliver precise, regulator-compliant multilingual regulatory submissions. Our specialized tools and platforms enable high-quality document formatting, thorough validation, and secure file management, ensuring that your submissions meet both technical and regulatory standards across global markets.

We use advanced formatting software including Adobe InDesign, Adobe FrameMaker, Microsoft Word, and professional PDF editors to structure documents according to agency specifications. Our experts optimize layouts for both print and electronic submissions while preserving linguistic accuracy and regulatory compliance.

For electronic submissions, we work with validated eCTD publishing tools such as Lorenz docuBridge, Extedo eCTDmanager, and other leading solutions. These platforms enable accurate assembly, bookmarking, hyperlinking, metadata tagging, and validation of submission-ready files that comply with ICH, FDA, EMA, and PMDA standards.

To strengthen the accuracy and integrity of every formatted document, we employ QA automation tools that verify pagination, section hierarchy, hyperlinks, document structure, and consistency across multilingual versions. Automated checks are complemented by human review for maximum reliability.

Sesen operates on secure, HIPAA- and GDPR-compliant platforms to protect sensitive regulatory documents. All files are managed through encrypted workflows with controlled access protocols to maintain client confidentiality and ensure full data protection throughout the formatting and submission process.

By combining expert human oversight with powerful technologies, Sesen ensures your multilingual regulatory documents are formatted accurately, securely, and in full compliance with international submission standards.

Industries and Regulatory Areas We Support

Sesen specializes in multilingual regulatory submission formatting for the life sciences industry, supporting companies across a wide range of sectors. Our expertise in regulatory requirements, document structuring, and multilingual DTP ensures that submissions are accurately formatted to meet the technical and compliance expectations of global health authorities.

We format regulatory documents for drug submissions, including NDAs, ANDAs, MAAs, and global clinical trial applications, ensuring alignment with ICH and regional authority standards.

Sesen supports biotech companies with the multilingual formatting of regulatory materials for biologics, gene therapies, and advanced therapies (ATMPs), tailored to country-specific guidelines.

Our team delivers compliant formatting for medical device submissions under MDR, IVDR, and FDA 510(k) or PMA processes, including IFUs, device labeling, and technical documentation.

We partner with CROs to format clinical study documentation for multinational trials, including CSRs, IBs, protocols, and informed consent documents, ready for submission to ethics committees and regulatory agencies.

Sesen provides formatting support for IVD and companion diagnostic regulatory submissions, ensuring that documentation meets global device and diagnostic-specific regulatory requirements.

We assist digital health companies and SaMD developers with formatting regulatory submissions for mobile apps, digital therapeutics, and AI-powered healthcare solutions, following guidelines from FDA, EMA, and regional authorities.

By combining deep regulatory expertise with advanced multilingual formatting capabilities, Sesen helps life sciences companies achieve faster approvals and successful global market access across all major industry segments.

Our Multilingual Capabilities for Regulatory Submissions

Sesen offers comprehensive multilingual support for regulatory submissions, combining expert translation with precise formatting across more than 150 languages. Our global network of professional native translators and regulatory specialists ensures that your submission documents meet both linguistic and technical standards for health authorities worldwide.

We have extensive experience formatting and localizing regulatory documents into high-demand submission languages, including Japanese, Chinese (Simplified and Traditional), German, French, Spanish, Portuguese, Korean, and Italian. Our teams understand the linguistic nuances, regulatory expectations, and regional formatting preferences critical for agency acceptance in each target market.

Sesen is fully equipped to manage simultaneous multi-language submissions for large-scale regulatory projects. Whether you are filing an NDA, MAA, PMA, or device registration across multiple countries, we synchronize translation and formatting workflows to deliver consistent, regulator-ready documents in all required languages—helping you meet tight global submission timelines without compromising quality or compliance.

Our multilingual capabilities ensure that your life sciences submissions are accurately translated, properly formatted, and fully aligned with the technical specifications of each target regulatory body.

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Why Choose Sesen for Regulatory Submission Formatting?

Sesen is a trusted partner for life sciences companies seeking accurate, compliant, and globally ready regulatory submission formatting. Our dedicated focus on the life sciences sector, combined with technical desktop publishing (DTP) expertise and deep regulatory knowledge, ensures that your multilingual documents meet the highest global standards.

We exclusively support pharmaceutical, biotechnology, medical device, CRO, and digital health companies with regulatory document translation and multilingual formatting tailored to industry-specific requirements.

Our team understands the submission standards and formatting expectations of the FDA, EMA, PMDA, NMPA, Health Canada, and other regulatory bodies worldwide, reducing the risk of submission delays or rejections.

Sesen integrates professional native translation, precision DTP, and rigorous regulatory validation processes to deliver fully compliant, submission-ready documentation across 150+ languages.

Whether you need multilingual formatting for a single clinical study report or a complete Common Technical Document (CTD) package across multiple markets, we scale our workflows to match your project size, complexity, and timelines.

All regulatory materials are managed through HIPAA- and GDPR-compliant platforms with strict version control, access restrictions, and end-to-end encryption, ensuring complete confidentiality and data security.

By choosing Sesen, you gain a partner who understands the technical, linguistic, and regulatory intricacies of multilingual submission success—helping you bring your innovations to global markets faster and with confidence.

Frequently Asked Questions (FAQs)

Yes. Sesen provides full formatting support for eCTD (electronic Common Technical Document) submissions. We structure translated documents according to ICH guidelines and regional specifications, ensuring correct granularity, hyperlinking, bookmarking, and file metadata. Our team works with leading eCTD publishing platforms like Lorenz docuBridge and Extedo eCTDmanager to prepare submission-ready documents that meet global health authority requirements.

We support a wide range of multilingual regulatory submissions, including NDAs, ANDAs, MAAs, INDs, PMAs, 510(k)s, device registrations, biologics licensing applications (BLAs), and clinical trial applications. Our expertise extends across pharmaceuticals, biotechnology, medical devices, diagnostics, digital health, and clinical research organizations (CROs), ensuring agency-compliant formatting for all types of regulatory documentation.

After formatting, every document undergoes a bilingual or multilingual linguistic review by professional native translators with regulatory experience. We validate that all translated content remains intact, accurate, and properly aligned post-formatting. Our QA process also includes layout checks, cross-link validation, and final content verification to guarantee full linguistic and technical integrity before submission.

Yes. We offer flexible, responsive support for last-minute updates, client-driven revisions, or agency feedback requests. Our project management team is equipped to implement formatting changes quickly across multilingual versions while maintaining compliance with submission requirements. We understand the fast-paced nature of regulatory filings and prioritize turnaround speed without compromising quality.

Sesen operates on HIPAA- and GDPR-compliant platforms to ensure the highest levels of data security and confidentiality. All project files are handled through encrypted channels, with strict access controls, secure versioning, and documented audit trails. We also offer non-disclosure agreements (NDAs) upon request to provide additional protection for sensitive regulatory documents.

Yes. Sesen localizes and formats regulatory submission templates to meet country-specific agency requirements, including variations in structure, labeling, annex organization, and regional metadata fields. We customize documents for agencies such as the FDA, EMA, PMDA, NMPA, and Health Canada, ensuring your submissions are formatted correctly for each regulatory body’s technical specifications and stylistic preferences. This localization helps streamline agency review processes and reduces the risk of formatting-related feedback.

Case Study: First-Pass Approval for Multilingual Regulatory Submissions

Challenge:
A leading biotechnology company needed to submit a New Drug Application (NDA) simultaneously to multiple global regulatory agencies, including the FDA, EMA, and PMDA. The submission required translation and formatting of more than 20 regulatory documents—including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Risk Management Plans (RMPs), and CTD Modules—into six languages within tight deadlines. The client faced pressure to maintain formatting compliance across all versions to avoid delays and agency rejections.

Sesen deployed a specialized team of life sciences translators, multilingual DTP experts, and regulatory project managers to manage the project. We performed translation, localized formatting, and rigorous regulatory validation across all target languages. Documents were prepared following each agency’s specific formatting requirements for eCTD and NeeS submissions, including precise pagination, cross-referencing, hyperlinking, and region-specific file naming conventions.

  • 100% first-pass approval of multilingual regulatory submissions with no formatting-related deficiencies reported by any regulatory agency.
  • 20% reduction in overall submission timeline, enabling the client to achieve simultaneous global filings ahead of schedule.
  • Zero agency rejections or document resubmission requests due to formatting, language, or structure issues.
  • Fully synchronized multilingual submissions, ensuring consistent quality across all languages and markets.

Through Sesen’s integrated translation and multilingual regulatory formatting services, the client successfully accelerated their global market access while maintaining full regulatory compliance.

Need Expert Multilingual Formatting for Your Regulatory Submissions?

Partner with Sesen to deliver regulator-ready, multilingual submission documents with precision, compliance, and speed. Our specialized team supports pharmaceuticals, biotech, medical devices, and CROs in achieving faster, error-free approvals across global markets.

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