Regulatory Submission Translation Services for the Pharmaceutical Industry
Sesen delivers accurate, compliant translations for INDs, NDAs, CTDs, and other regulatory dossiers—trusted by pharmaceutical companies worldwide. Our multilingual life sciences experts ensure your global submissions meet the highest linguistic and regulatory standards.
Why Regulatory Submission Translation Matters
Global regulatory bodies—including the FDA (U.S.), EMA (Europe), PMDA (Japan), NMPA (China), and Health Canada—require precise, country-specific documentation for pharmaceutical product approvals. Submitting translated dossiers that meet each agency’s format and language requirements is not optional—it’s essential for market access.
Mistranslations or inconsistencies can lead to questions from regulators, application rejections, or costly delays, posing serious regulatory translation risks. Errors in terminology, context, or formatting may result in noncompliance with local submission guidelines, undermining your timeline and regulatory strategy.
High-quality translations that maintain linguistic accuracy and scientific integrity are critical to meeting regulatory submission requirements. At Sesen, we ensure full compliance in pharmaceutical translations by aligning with ICH guidelines, regional standards, and therapeutic-area terminology—accelerating approvals and reducing risk.
Sesen’s Expertise in Regulatory Translation
Sesen specializes in regulatory dossier translation for all major submission types, including IND, NDA, BLA, ANDA, MAA, and CTA filings. Our team of professional native linguists combines deep pharmaceutical knowledge with regulatory domain expertise, ensuring accurate, context-sensitive translations tailored to each region’s requirements.
Every project is managed under our ISO 17100 and ISO 9001 certified quality systems, with rigorous review by subject matter experts to validate scientific accuracy and terminology usage. We maintain consistency across complex submission packages—such as CTD module translations—through the use of validated translation memory tools and client-specific terminology management systems.
Whether you're preparing an EMA submission translation or supporting a global rollout, Sesen delivers regulatory translations that meet the highest standards of clarity, compliance, and precision.
Types of Documents We Translate
Sesen provides end-to-end regulatory translation services for a wide range of document types required by global health authorities. Our linguists and regulatory experts ensure each translation meets the necessary formatting, terminology, and compliance standards—on time and submission-ready.
IND (Investigational New Drug Applications)
Sesen translates INDs with precision, supporting early-phase clinical trial approvals in the U.S. and other markets. Our team ensures consistency across scientific, administrative, and safety content to meet FDA expectations.
NDA (New Drug Applications)
Our regulatory linguists deliver accurate translations of NDAs, aligning with FDA and ICH standards. Sesen supports your full submission package, including labeling, CMC data, and clinical study modules.
Common Technical Document (CTD) Modules 1–5
Sesen offers full-service CTD translation services, covering Modules 1 through 5. We ensure technical, clinical, and regional content is translated with precision to support global submissions to the EMA, PMDA, and other agencies.
Investigator’s Brochures
We translate IBs for use in multi-country clinical trials, maintaining the integrity of scientific data and safety information. Sesen’s reviewers ensure terminology accuracy across investigational compounds.
Clinical Study Protocols and Reports
Sesen provides specialized clinical trial documentation translation for protocols, CSR summaries, and related documentation, ensuring regulatory compliance and scientific clarity in every language.
Patient Information Leaflets and Informed Consent Forms
Our translations of PILs and ICFs ensure clear, patient-friendly language while meeting local ethical and regulatory requirements. Sesen helps sponsors improve global enrollment and compliance through culturally adapted translations.
Chemistry, Manufacturing and Controls (CMC) Documentation
We support accurate translation of complex CMC data, including process descriptions, analytical methods, and specifications. Sesen ensures alignment with GxP and regulatory authority expectations.
Product Labels and Packaging
Sesen translates product labels, folding cartons, and inserts in accordance with country-specific labeling laws, including EMA QRD templates and FDA requirements. We ensure both linguistic accuracy and formatting compliance.
Risk Management Plans (RMPs)
Our experts handle pharmacovigilance translations such as RMPs with attention to terminology and local pharmacovigilance guidance. Sesen ensures safety information is clearly communicated across all target markets.
Periodic Safety Update Reports (PSURs)
Sesen delivers precise PSUR translations to support ongoing regulatory compliance post-approval. Our team ensures consistency with core safety data sheets and region-specific templates.
Quality Overall Summaries (QOS)
We translate QOS documents with an emphasis on consistency, clarity, and scientific accuracy—ensuring your summary aligns with the full dossier and meets regulatory review expectations.
Regulatory Bodies and Regions We Support
Sesen delivers regulatory submission translation services tailored to the specific requirements of leading health authorities around the world. Our team understands the linguistic, technical, and formatting nuances required for successful global filings—ensuring your translations align with agency expectations in every target region. We support submissions to the following regulatory bodies:
EMA (European Medicines Agency)
Translation support for centralized, decentralized, and mutual recognition procedures across the EU.
FDA (U.S. Food and Drug Administration)
U.S.-compliant translations for INDs, NDAs, BLAs, ANDAs, and labeling requirements.
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Localized regulatory translations that adhere to Japanese standards and terminology.
NMPA (National Medical Products Administration, China)
Translation services aligned with evolving Chinese regulatory submission formats and language requirements.
Health Canada
Bilingual (English and French) submissions and compliance-focused translations for clinical and commercial-stage filings.
MHRA (Medicines and Healthcare Products Regulatory Agency, UK)
Post-Brexit regulatory translation support for UK-specific requirements.
ANVISA (Brazilian Health Regulatory Agency)
Brazilian Portuguese translations for pharmaceutical and medical product submissions.
TGA (Therapeutic Goods Administration, Australia)
Translation of technical and clinical documents for TGA-regulated therapeutic goods.
MFDS (Ministry of Food and Drug Safety, South Korea)
Korean-language regulatory translations that comply with MFDS documentation standards.
GCC-DR (Gulf Central Committee for Drug Registration)
Multilingual support for submissions across GCC member states, including Arabic translation services.
Sesen’s global expertise helps pharmaceutical companies navigate complex regional regulatory environments with confidence, speed, and compliance.
Quality Assurance and Compliance Processes
At Sesen, quality and compliance are built into every step of our regulatory submission translation services. Our structured workflows and rigorous validation processes ensure linguistic accuracy, technical precision, and full regulatory alignment.
Dual-Review Translation Workflow
Each submission undergoes a multi-step process, including initial translation by a qualified linguist and independent review by a second linguist with subject matter expertise. This ensures consistency, clarity, and compliance with regulatory terminology.
Regulatory-Trained Linguists
All translators are trained in ICH guidelines, GxP requirements, and region-specific submission protocols. This guarantees accurate interpretation of scientific and regulatory content across all target languages.
Version Control and Audit Trails
We maintain complete traceability for every project. Our TMS supports version control, audit trails, and revision tracking—critical for regulatory documentation subject to inspection and re-submission.
Data Security and Confidentiality
Client data is handled with strict confidentiality protocols. Our translation management system is hosted on Amazon Web Services (AWS), providing enterprise-grade security, redundancy, and data encryption to meet regulatory data protection standards.
Sesen’s compliance-focused approach reduces risk and ensures your translations are audit-ready, regulator-facing, and submission-approved.
Technology-Enabled Human Translation
Sesen combines advanced linguistic technology with expert human oversight to deliver accurate, regulator-ready regulatory submission translations at scale. Our hybrid approach improves efficiency while maintaining the highest standards of quality and compliance.
Computer-Assisted Translation (CAT) Tools
We leverage leading CAT tools to ensure consistency across large and multi-language submissions. These tools support structured translation workflows, reduce turnaround times, and enhance translator productivity.
Context-Aware Terminology Management
Our proprietary terminology management solutions dynamically adapt to the therapeutic area, regulatory framework, and product-specific language. This ensures consistent use of critical terms across all submission documents, reducing risk and reviewer queries.
AI-Driven Linguistic QA Checks
Sesen employs AI-powered quality assurance algorithms to flag potential inconsistencies, formatting issues, and compliance gaps in real time—serving as a secondary safeguard before final human review.
Machine Translation Post-Editing (MTPE)
For high-volume, non-critical content, we offer MTPE services to improve speed and cost-efficiency. All output is carefully post-edited by qualified linguists to meet regulatory and linguistic standards.
Client System Integration
Our translation environment integrates seamlessly with sponsor systems—including eCTD platforms and document management systems—for automated content exchange and scalable project handling.
Human Oversight for Critical Content
While we use technology to enhance quality and speed, Sesen never compromises on human expertise. All critical regulatory documents are reviewed and validated by experienced linguists and subject matter experts to ensure compliance and accuracy.
Sesen’s technology-enabled approach supports faster timelines, higher consistency, and greater confidence in every submission—without sacrificing quality or control.
Why Pharmaceutical Companies Trust Sesen
Global pharmaceutical and biotech companies rely on Sesen for critical regulatory submission translation services—from early-phase clinical trials to global market approvals. Our proven track record, deep domain expertise, and commitment to quality have earned us long-term partnerships across the life sciences industry.
Trusted by Leading Sponsors
Sesen has supported regulatory submissions for some of the world’s top 20 pharmaceutical companies, including INDs, NDAs, MAAs, and global CTD dossiers. Our clients count on us for precision, responsiveness, and regulatory fluency.
Experience Across Therapeutic Areas
We’ve successfully delivered multilingual regulatory translations in oncology, neurology, rare diseases, infectious diseases, immunology, and more—adapting to complex clinical and technical content.
Strategic, Long-Term Relationships
Many of our clients choose Sesen as a preferred language services provider for regulatory and clinical programs spanning multiple regions and phases. We integrate with internal teams to deliver scalable, deadline-driven solutions.
Proven Performance
In a recent global Phase III submission project involving 23 languages and 180,000+ words, Sesen achieved 100% on-time delivery with zero revision cycles during regulatory review.
“Sesen has been a critical partner in helping us navigate multilingual submissions. Their regulatory knowledge, language precision, and responsiveness consistently exceed expectations.”
— Director, Regulatory Affairs, Leading Medical Technology Company
Whether it’s a high-stakes NDA filing or ongoing post-marketing updates, pharmaceutical companies trust Sesen to deliver quality, accuracy, and compliance—every time.
Project Management and Client Support
Sesen delivers more than high-quality regulatory submission translation services—we provide expert-driven project management and responsive client support to keep your global filings on track.
Dedicated Regulatory Project Managers
Each project is led by a dedicated project manager with experience in pharmaceutical regulatory workflows. They understand the nuances of INDs, NDAs, MAAs, and CTD submissions, ensuring precise coordination from kickoff through final delivery.
Structured Reporting and Milestone Tracking
Sesen provides weekly progress reports, real-time status updates, and proactive communication to keep your team informed. We track deliverables by module, language, and timeline, so you always know where things stand.
Rapid Turnaround for Urgent Submissions
Whether you’re facing a health authority request or a compressed submission timeline, Sesen is equipped to manage accelerated and high-volume translation needs—across multiple languages and time zones.
Our client-centric approach ensures transparent collaboration, predictable timelines, and regulatory-aligned results—backed by a team that understands the pressure and precision required in life sciences.
