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multilingual-vaccine-submission

Overview

A leading global pharmaceutical company engaged Sesen to support a time-sensitive multilingual vaccine submission to the World Health Organization (WHO) and over 7 national regulatory authorities across Europe, Asia, and Latin America. The project involved the translation and localization of a complete Common Technical Document (CTD) package, including Product Information (PI), Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs), and Instructions for Use (IFUs), into more than a dozen languages.

Due to the urgency of the submission, driven by global health priorities and evolving regulatory timelines, Sesen was tasked with delivering high-quality, compliant translations under accelerated deadlines. Accuracy, linguistic consistency, and regulatory adherence were critical to avoid delays or rejections from health authorities.

Sesen deployed a centralized, scalable workflow that combined native-speaking regulatory linguists, in-country validation, and rigorous quality assurance to ensure each translated dossier met local submission standards. The result was a successful on-time submission across all jurisdictions with validated, harmonized multilingual content, reinforcing Sesen’s position as a trusted partner for global pharmaceutical translation solutions.

Client Context

The client is a global pharmaceutical company recognized for its innovation and leadership in vaccine development. With an established portfolio of immunization products distributed in over 100 countries, the organization plays a critical role in addressing global public health challenges.

This project centered around a newly developed vaccine targeting a high-priority infectious disease, designated for accelerated review by international and national health agencies. The product was identified for emergency use or fast-track authorization, increasing the urgency and regulatory scrutiny of all supporting documentation.

To secure global market access, the client was required to submit multilingual regulatory dossiers simultaneously to the World Health Organization (WHO) and more than 7 national regulatory authorities, including the European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, National Medical Products Administration (NMPA) in China, and Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil. Each authority had specific language, format, and content requirements, necessitating a highly coordinated translation and localization strategy to maintain consistency across jurisdictions while meeting local compliance standards.

The Challenge

The client faced an aggressive submission timeline driven by pandemic-related urgency and international demand for rapid vaccine deployment. Regulatory bodies, including the WHO and multiple national health authorities, required simultaneous dossier submissions to support emergency use authorization or fast-track approval. Missing key deadlines could result in significant delays in patient access and market entry.

The scope of the project spanned 7 target languages and involved a wide range of document types, including Common Technical Document (CTD) Modules, Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), Instructions for Use (IFUs), and product labeling. Each file required precise, compliant translation aligned with country-specific formatting and linguistic expectations.

A major complexity stemmed from differing regulatory requirements across jurisdictions. Guidelines from agencies such as EMA, PMDA, NMPA, and ANVISA varied in structure, terminology, and submission protocols. Additionally, terminology standards and regional language nuances introduced challenges in achieving consistent interpretation and presentation of product claims and instructions.

Coordinating with regional regulatory teams, in-country reviewers, and global RA stakeholders required structured alignment, real-time communication, and a robust project management approach. Sesen needed to ensure that all translated materials met local regulatory expectations while preserving global consistency and scientific accuracy.

Sesen’s Solution

To meet the demands of simultaneous vaccine submissions to WHO and over 7 national authorities, Sesen implemented a highly coordinated, technology-enabled translation solution tailored for global regulatory compliance. The approach balanced speed, linguistic accuracy, and submission-readiness across all target markets.

A. Customized Translation Workflow

Sesen assigned a dedicated life sciences project management team to oversee the full translation lifecycle from intake to final delivery. Our centralized coordination model ensured consistency across document types and target languages, while streamlining communication with the client’s global regulatory affairs (RA) and local affiliate teams.

We deployed professional native linguists with specialized expertise in vaccines and regulatory content. Translators were selected based on subject matter proficiency and prior experience with WHO and national authority submissions. Early in the project, we worked closely with the client to define a centralized glossary, style guide, and regulatory terminology framework, which were applied consistently across all materials to support harmonization. This structured approach reflects Sesen’s broader regulatory translation services framework.

B. Scalable Linguistic Validation

Sesen implemented a dual-layer quality assurance process to safeguard linguistic and regulatory integrity. This included centralized QA checks by our in-house life sciences editors followed by in-country review conducted by local regulatory experts. This approach ensured that all content was both scientifically accurate and locally compliant, reducing the risk of rework or rejection.

We also conducted cross-language consistency reviews to verify alignment of key data points, product names, and claims across all target languages and document versions. These validation practices are part of Sesen’s broader linguistic validation services.

C. Technology Integration

Our secure translation environment leveraged translation memory (TM) and a centralized terminology database to maximize efficiency, reduce turnaround time, and enhance consistency. These assets were updated in real time and shared across all language teams.

Project tracking and communication were managed via Sesen’s secure client portal, providing stakeholders with real-time visibility into progress, feedback cycles, and delivery milestones. This transparency helped align global RA and local affiliate teams throughout the project.

D. Compliance and Confidentiality

Sesen’s workflows adhere to ISO 17100 for translation quality, ISO 13485 for medical device documentation processes, and GDPR for data protection. All files were managed within an encrypted digital infrastructure, and all linguists and reviewers were bound by NDAs and contractual confidentiality agreements.

Our secure file delivery system ensured tamper-proof transfers, while access controls limited visibility to authorized stakeholders only. These safeguards supported regulatory compliance while protecting sensitive product information.

Results

Sesen successfully delivered all translated regulatory dossiers within the accelerated timelines required by the World Health Organization (WHO) and over 7 national regulatory authorities. Despite the project’s complexity and urgency, the submission met every jurisdiction’s linguistic and formatting requirements without delay.

There were zero rejections, revisions, or language-related follow-up requests from WHO, EMA, PMDA, NMPA, ANVISA, or any other participating health authority. This outcome validated the strength of Sesen’s quality assurance model and in-country linguistic review process.

Over 30 individual documents were translated, quality-checked, and finalized in alignment with each authority’s submission specifications. Terminology and formatting consistency were maintained across all language versions of the Common Technical Document (CTD), SmPCs, PILs, IFUs, and product labels.

The success of this high-stakes engagement reinforced the client’s confidence in Sesen’s ability to manage large-scale, multilingual vaccine submissions. The client has since expanded its partnership with Sesen to include ongoing regulatory translation support for new indications, label updates, and global product launches.

Client Feedback

Following the successful completion of the project, the client’s global regulatory affairs lead praised Sesen’s ability to manage multilingual complexity while maintaining regulatory precision under tight timelines.

“Sesen delivered on every front: speed, quality, and consistency. Their attention to regulatory detail made this high-stakes submission process seamless across all countries. From terminology alignment to country-specific formatting, every aspect was handled with expertise and professionalism. We look forward to continuing our partnership on future global submissions.”
The testimonial underscores Sesen’s role not only as a translation vendor but as a strategic partner capable of supporting critical regulatory milestones through scalable, compliant, and validated language solutions.

Key Takeaways

Global vaccine submissions require more than just accurate translations—they demand centralized coordination, regulatory insight, and proven quality control. This project demonstrated how Sesen’s integrated approach to multilingual regulatory translation enables pharmaceutical companies to meet tight timelines, reduce compliance risk, and ensure consistency across international markets.

By centralizing translation management under a dedicated life sciences team, Sesen eliminated fragmentation, minimized errors, and streamlined stakeholder communication. The combination of linguistic precision and deep regulatory expertise ensured that each submission met country-specific requirements while preserving the scientific integrity of the source content.

The use of in-country validation and multi-layered quality assurance significantly reduced the risk of rework, rejection, or delay. This proactive validation process is essential for life sciences organizations navigating evolving global health regulations and multilingual dossier submission requirements.

Sesen’s scalable and compliant framework offers a blueprint for pharmaceutical and biotech companies seeking a trusted partner to support complex, high-stakes regulatory submissions across multiple jurisdictions.

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Need Expert Help with Multilingual Vaccine Submissions?

Ensure your regulatory dossiers are translated accurately, reviewed locally, and delivered on time. Sesen specializes in compliant, high-volume vaccine submissions for WHO and national authorities in over 150 languages.

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