Key Challenges in Regulatory Translation for Global Submissions

Accurate and compliant translation is essential for successful regulatory submissions in the life sciences sector. As pharmaceutical, biotech, and medical device companies expand into international markets, they must prepare multilingual dossiers that meet the specific requirements of global regulatory bodies. Each authority—whether the EMA, FDA, PMDA, or NMPA—has its own submission standards, terminology, and formatting expectations that must be followed precisely.

Even minor language errors or inconsistencies in translated content can lead to delayed approvals, regulatory queries, or outright rejections. The stakes are high, particularly for documents supporting clinical trial applications, marketing authorizations, and product labeling.

Sesen specializes in life sciences translation with a focus on regulatory accuracy, linguistic consistency, and technical precision. Our expert linguists and dedicated project managers support global submissions across major health authorities, helping clients avoid costly setbacks and accelerate product access to market.

Why Regulatory Translation Is Mission-Critical

Regulatory translation plays a central role in obtaining drug approvals, clinical trial authorization, and medical device certification across global markets. Health authorities such as the EMA, FDA, PMDA, and NMPA require precise, fully localized documentation in the target language to evaluate product safety, efficacy, and quality.

Successful submissions depend on the accuracy of translated protocols, investigator brochures, product labels, and summary reports. Language precision, terminology consistency, and strict adherence to regulatory formatting are critical to avoid misinterpretation and delays. Translators must align with standard medical and regulatory lexicons, including ICH, MedDRA, and region-specific glossaries.

As life sciences companies expand internationally, the volume and complexity of multilingual submissions have increased. Each jurisdiction has evolving linguistic, structural, and procedural requirements, making regulatory translation a specialized discipline that demands deep subject matter expertise and workflow validation. Errors in this process can lead to rejection, resubmission, or loss of market opportunity.

1. Regional Terminology and Regulatory Language Variations

Accurately aligning terminology across global regulatory agencies is one of the most complex aspects of multilingual submissions. Each agency uses distinct regulatory language, abbreviations, and expectations that must be translated with precision and full contextual awareness.

For example:

• • • EMA (Europe) requires strict adherence to terms such as QPPV (Qualified Person for Pharmacovigilance), SmPC (Summary of Product Characteristics), and RMP (Risk Management Plan).
    • FDA (USA) relies on terminology specific to INDs, NDAs, and BLAs, with critical differences in how clinical and manufacturing data are presented.
    • PMDA (Japan) demands accurate localization of GCP documentation and detailed formatting requirements unique to Japanese regulatory submissions.
    • NMPA (China) mandates translation into Simplified Chinese with special attention to structural compliance, character encoding, and local linguistic nuance.

These regional variations make it essential to work with in-country reviewers and regulatory experts who understand local expectations. Using validated multilingual glossaries, regulatory style guides, and agency-specific reference materials ensures linguistic consistency and compliance.

Sesen supports regulatory teams with expert-managed terminology workflows and centralized linguistic assets tailored for each submission region.Learn more about our Glossaries & Style Guides.

2. Submission Format and Layout Compliance

Regulatory submissions must meet strict formatting and layout standards that vary across agencies. Whether submitting through eCTD, NeeS, or paper-based channels, life sciences companies are required to follow specific structural guidelines that govern document organization, file types, pagination, and metadata.

Formatting challenges increase with multilingual content, especially when working with right-to-left languages, double-byte character sets (such as Chinese, Japanese, and Korean), and documents containing complex tables, line breaks, and visual elements. Regulatory authorities often reject submissions due to formatting inconsistencies or technical issues in file rendering.

Each agency imposes unique format standards. For example:

• • • The EMA requires adherence to QRD (Quality Review of Documents) templates for product labeling and SmPCs.
    • The FDA mandates submissions using Structured Product Labeling (SPL) and XML formatting for certain files.

High-quality desktop publishing (DTP) is essential to ensure all translated documents retain the original layout, meet formatting compliance, and are ready for electronic upload without further revision. Specialized DTP teams also adjust fonts, spacing, and table alignment to accommodate translated text without compromising structure.

Sesen provides end-to-end regulatory DTP services alongside translation, ensuring final deliverables meet regional formatting requirements and submission-readiness standards across all health authorities.

3. Managing Multilingual Versions Across Submissions

Maintaining consistency across multilingual regulatory documents is a major operational challenge for life sciences organizations. Global submissions often span over 100 pages and must be localized into multiple languages for concurrent review by different health authorities. Ensuring linguistic alignment, formatting uniformity, and data consistency across all language versions is both complex and time-sensitive.

As source documents evolve through multiple rounds of revision, updated content must be accurately reflected across all translated versions without introducing discrepancies. Delays or errors in this synchronization process can result in inconsistent submissions that raise regulatory red flags or require costly rework.

To address these challenges, leading organizations implement Translation Memory (TM) tools and structured version control systems that allow for efficient reuse of approved language segments and precise tracking of document changes. This ensures consistency at both the sentence and terminology level, while reducing turnaround times and translation costs.

Successful multilingual version management also depends on coordinated communication across internal stakeholders, including regulatory affairs, legal, clinical, and commercial teams. Clear workflows and centralized language assets help streamline review cycles and maintain control over submission quality across all markets.

Sesen delivers fully managed multilingual translation workflows backed by centralized TMs, audit-ready version tracking, and dedicated project teams experienced in global regulatory coordination.

4. Tight Timelines and Late-Stage Changes

Regulatory submissions are often subject to aggressive timelines and frequent late-stage updates. Whether due to evolving clinical data, updated labeling requirements, or agency feedback, changes can occur just days before submission deadlines. These time constraints place significant pressure on translation workflows, where delays can directly impact product launch schedules and market access.

Late-stage revisions introduce added complexity, requiring immediate retranslation, desktop publishing, and quality assurance without compromising accuracy or compliance. Any error introduced during a rushed update may trigger regulatory queries, delay approval, or necessitate resubmission.

In this high-pressure environment, working with a translation partner that offers on-demand capacity and 24/7 support is critical. The ability to rapidly mobilize linguists, project managers, and DTP specialists ensures that updates are handled quickly and efficiently, regardless of time zone or volume.

Sesen is equipped to support urgent translation needs with scalable resources and proven turnaround workflows. Our teams have delivered critical updates under tight deadlines for global pharmaceutical clients, helping them meet regulatory submission dates without sacrificing quality or compliance.

5. Data Privacy, Security, and Regulatory Integrity

Regulatory translation projects often involve sensitive and confidential data, including clinical results, manufacturing processes, and proprietary product information. Ensuring data privacy and protection throughout the translation lifecycle is a critical requirement, particularly when working across regions with strict legal frameworks such as GDPR in Europe, HIPAA in the United States, and the China Cybersecurity Law (CSL).

Compliance with internationally recognized standards such as ISO 17100 for translation services and ISO 9001 for quality management reinforces the integrity of the translation process. These certifications establish clear guidelines for quality assurance, risk mitigation, and traceability in multilingual content delivery.

To safeguard client data, Sesen utilizes secure translation environments, including VPN-protected workflows, encrypted file transfer protocols, and restricted platform access. All linguists and project team members operate under signed confidentiality agreements, and data is stored in fully compliant infrastructures.

Sesen is hosted on Amazon Web Services (AWS), leveraging its advanced security architecture, including server-side encryption, real-time monitoring, and controlled access management. This ensures that all translation activities meet the highest standards for information security and regulatory compliance.

6. Cultural and Linguistic Accuracy for Labeling & Patient-Facing Content

Translating patient-facing materials requires more than regulatory compliance—it demands cultural and linguistic precision to ensure clarity, comprehension, and public safety across target populations. Documents such as patient information leaflets (PILs), instructions for use (IFUs), medication guides, and package inserts must adhere to both formal regulatory requirements and informal communication norms of each local market.

Literal translation of medical content can result in ambiguity or misunderstanding, especially when instructions are intended for patients with varying levels of health literacy. Tone, terminology, and phrasing must be carefully adapted to reflect cultural expectations while maintaining the intended meaning and legal accuracy of the original content.

Many countries require linguistic validation or back-translation of patient materials to verify that localized versions are accurate, user-friendly, and appropriate for local populations. This is particularly important for high-risk devices, pediatric treatments, or chronic disease therapies where patient adherence depends on clear, accessible instructions.

Sesen applies a dual focus on regulatory compliance and cultural adaptation, leveraging in-market linguists and medical reviewers to deliver labeling content that meets the standards of both health authorities and local communities. Learn more about our Drug Labeling & Packaging Translation services.

How Sesen Helps Overcome These Challenges

Sesen provides comprehensive, end-to-end translation solutions that address the full spectrum of challenges faced by life sciences companies preparing global regulatory submissions. Our services are tailored to support clinical, regulatory, and commercial teams throughout the product development lifecycle.

We manage multilingual submissions across all major regulatory pathways, including IND, NDA, MAA, ANDA, DMF, and related filing types. Whether translating clinical protocols, quality documentation, or product labeling, our team ensures each deliverable meets region-specific linguistic and technical standards.

Each project is overseen by a dedicated project manager with deep regulatory translation experience and a clear understanding of submission timelines, content types, and quality expectations. Sesen also applies technology-enabled human translation, combining advanced translation memory tools and secure AI-assisted workflows with qualified native linguists to improve consistency, speed, and cost-efficiency without compromising compliance.

Our proven track record includes supporting multi-agency submissions for global pharmaceutical and medical device companies, where synchronized translations were delivered across multiple languages and formats under tight deadlines. These projects were completed with full adherence to EMA, FDA, and PMDA requirements, allowing our clients to proceed confidently with their filings.

Sesen’s integrated approach reduces risk, shortens timelines, and delivers submission-ready content that meets the highest standards of accuracy, security, and regulatory integrity.

Agencies We Support

Sesen supports global regulatory submissions across all major health authorities, ensuring accurate, compliant translations tailored to each agency’s specific linguistic, formatting, and procedural standards. Our expert linguists and regulatory specialists are experienced in navigating diverse regional requirements to help clients achieve faster approvals and reduce compliance risks.

We regularly provide translation services for the following regulatory bodies:

• EMA (European Medicines Agency) – Centralized submissions, QRD templates, and multilingual SmPCs
• FDA (U.S. Food and Drug Administration) – IND, NDA, BLA, SPL, and labeling content
• PMDA (Pharmaceuticals and Medical Devices Agency, Japan) – GCP documentation, quality data, and localized patient materials
• NMPA (National Medical Products Administration, China) – Simplified Chinese translations, eCTD formatting, and CSL-compliant workflows
• TGA (Therapeutic Goods Administration, Australia) – Product registrations and labeling for pharmaceuticals and devices
• Health Canada – Bilingual (English and French) submissions, monograph adaptation, and patient labeling
• ANVISA (Brazilian Health Regulatory Agency) – Portuguese translations of clinical and CMC documents
• MHRA (Medicines and Healthcare products Regulatory Agency, UK) – UK-specific regulatory filings post-Brexit

We also support regional filings with additional health authorities across Southeast Asia, the Middle East, and Latin America. Whether submitting through centralized or national procedures, Sesen delivers language solutions that meet each agency’s expectations with accuracy and speed.

Related Services

Sesen provides a full range of specialized translation services to support regulatory, clinical, and commercial teams across the life sciences industry. Each service is tailored to meet stringent quality, compliance, and formatting standards required by global health authorities.

• Clinical Trial Document Translation: Accurate translation of protocols, IBs, ICFs, and site correspondence to support global trial execution and ethics committee approvals.
• IFU Translation: Multilingual translations of Instructions for Use in compliance with EU MDR, FDA UDI, and other regional labeling regulations.
• Medical Device Translation: Regulatory, technical, and labeling translations for Class I, II, and III devices, aligned with IEC 62366, ISO 14971, and other device standards.
• Regulatory Submission Translation: End-to-end translation of Module 1–5 documents for eCTD, NeeS, and paper-based submissions across major regulatory pathways.
• SOP Translation: Compliant translation of standard operating procedures for QA, manufacturing, clinical, and pharmacovigilance teams, with formatting for audit-readiness.
• GMP and Manufacturing Translation: Translations of batch records, quality reports, and process documents in compliance with FDA 21 CFR, EMA Annexes, and ICH Q7–Q10 guidelines.

These services are fully integrated into Sesen’s technology-enabled translation workflows, supporting faster turnaround, cost-efficiency, and consistent terminology across all regulated content.

FAQs

What types of regulatory documents do you translate?

Sesen translates a wide range of regulatory documents, including clinical trial applications (IND, CTA), marketing authorization dossiers (NDA, MAA, ANDA), CMC sections, investigator brochures, product labels, SmPCs, RMPs, IFUs, SOPs, and pharmacovigilance reports. We support all ICH CTD modules, as well as eCTD and NeeS formats.

How do you handle region-specific terminology?

We use validated, region-specific glossaries aligned with EMA QRD templates, FDA terminology, and other regulatory authority standards. Our linguists are trained in local regulatory language, and all projects are reviewed by in-country experts to ensure compliance with terminology requirements.

Are your translations compliant with ISO standards?

Yes. Sesen is certified to ISO 17100 for translation services and ISO 9001 for quality management. Our workflows follow strict QA protocols, including multi-step review, linguistic validation when needed, and full audit trails to ensure consistent, high-quality deliverables.

Can you handle urgent updates or resubmissions?

We provide 24/7 global coverage to support urgent translation needs, including last-minute changes and resubmissions. Our scalable linguist network and dedicated project managers are equipped to turn around high-priority updates without compromising quality or regulatory integrity.

How do you ensure translation accuracy and consistency?

We combine subject matter expertise with advanced tools such as Translation Memory (TM) and terminology management systems. Each project undergoes bilingual review, formatting QA, and version control to maintain consistency across all submission components and target languages.

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