Global Compliance Starts with Clear Communication
In today’s globally regulated environment, multilingual communication is essential for public health agencies, regulatory authorities, and government institutions managing life sciences data. Accurate and timely translation ensures transparency, supports international collaboration, and facilitates the successful submission and approval of critical documentation.
Sesen delivers high-precision translations for regulatory and government entities, combining linguistic excellence with deep domain expertise. Our commitment to compliance, data confidentiality, and technical accuracy aligns with the rigorous standards of agencies such as the FDA, EMA, PMDA, MHRA, and Health Canada. Whether supporting cross-border clinical trials, public health initiatives, or regulatory submissions, Sesen is a trusted language partner to government bodies around the world.
Trusted by Public Institutions Worldwide
Sesen supports a wide range of government and regulatory stakeholders involved in the development, regulation, and oversight of life sciences. Our specialized translation services enable these organizations to communicate effectively across borders, meet regulatory mandates, and disseminate critical information to global audiences.
We work with:
Government Health Agencies
Including the CDC, NIH, and WHO-affiliated organizations, for the translation of research findings, public health guidance, and health communication campaigns.
Regulatory Authorities
Such as the FDA, EMA, PMDA, and other national regulatory bodies, providing certified translations for drug approvals, device clearances, and regulatory correspondence.
Public Health Institutions
Translating epidemiological reports, health advisories, and policy frameworks to support global health initiatives and community outreach.
NGOs & International Organizations
Assisting humanitarian and development programs with multilingual materials for training, awareness, and compliance across multiple jurisdictions.
Import/Export and Border Control Agencies
Supporting customs compliance and the cross-border movement of medical products through precise translation of import permits, declarations, and regulatory documentation.
Ministries of Health
Delivering accurate translations for healthcare regulations, treatment protocols, and multilingual public service announcements.
State, Federal, and Municipal Government Departments
Enabling clear, compliant communication for health services, procurement programs, emergency response, and interagency collaboration.
Regulatory Precision Across Every Document Type
Sesen provides expert translation services for a broad range of document types critical to regulatory compliance, public health operations, and government-led life sciences initiatives. Our linguists and subject-matter experts ensure terminological accuracy and adherence to jurisdiction-specific requirements across all deliverables.
We specialize in translating:
Regulatory Submissions
Including INDs, NDAs, ANDAs, BLAs, and MAAs—localized for target authorities such as the FDA, EMA, PMDA, and others.
Public Health Communications
Health advisories, announcements, and multilingual outreach materials for community awareness and crisis response.
Compliance Documentation & Safety Reports
Pharmacovigilance reports, periodic safety updates (PSURs), and risk management plans tailored for regulatory review.
Standard Operating Procedures (SOPs)
Operational documentation for internal compliance, quality management systems, and clinical site requirements.
Freedom of Information Act (FOIA) Responses
Confidential and time-sensitive document translations for legal and public disclosure.
Training and Policy Manuals
Materials for staff training, regulatory protocol alignment, and internal knowledge dissemination.
Medical Device Regulatory Filings
Technical files, labeling, IFUs, and CE marking documentation in accordance with MDR and FDA requirements.
Clinical Trial Documentation
Protocols, informed consent forms (ICFs), investigator brochures, and IRB/ethics submissions.
Import/Export Permits and Customs Documents
Regulatory documents for the international shipment of drugs, biologics, and medical devices.
Emergency Response Guidelines
Multilingual guidance for pandemic response, disaster preparedness, and crisis communications.
Government-Funded Research Reports
Scientific publications, grant deliverables, and white papers produced under public or intergovernmental funding.
Multilingual Coverage for Global Regulatory Reach
Sesen provides specialized life sciences translations in over 100 languages to support global regulatory compliance and cross-border communication. Our language services cover all official languages of ICH member countries, the European Union, and key pharmaceutical and medical device markets across Asia, Latin America, the Middle East, and Africa.
We offer deep expertise in:
EU and EEA Languages
Including French, German, Spanish, Italian, Dutch, Polish, and the Nordic languages, aligned with EMA and local health authority requirements.
Asian Markets
Japanese, Chinese (Simplified and Traditional), Korean, Thai, and Vietnamese for PMDA submissions and APAC regional compliance.
Latin American Languages
Spanish (LATAM variants), Portuguese (Brazil), supporting ANVISA and regional public health programs.
Middle Eastern and African Languages
Arabic, Turkish, Swahili, and others, ensuring accessibility for WHO-affiliated initiatives and local regulatory frameworks.
North American Requirements
English (US and CA), French (Canada), and Spanish (US), compliant with FDA and Health Canada standards.
Whether your project requires multilingual regulatory submissions, public health messaging, or cross-agency documentation, Sesen ensures language accuracy and regulatory alignment at every step.
Built for Compliance. Driven by Quality.
Sesen delivers translation solutions that meet the highest quality standards demanded by global regulatory and government agencies. Our workflows are designed to support strict compliance, technical precision, and full auditability across every engagement.
Certified to International Standards
ISO 17100 (Translation Services), ISO 9001 (Quality Management), and ISO 13485 (Medical Devices) form the foundation of our quality assurance framework.
Regulatory Translation Expertise
All deliverables align with the linguistic, formatting, and compliance expectations of global health authorities, including FDA, EMA, PMDA, and Health Canada.
Certified and Notarized Translations
Available upon request to meet official submission requirements or legal documentation standards.
Multi-Step QA/QC Processes
Every project undergoes structured translation, editing, and proofreading (TEP) with built-in linguistic validation and final quality control reviews.
Specialized Regulatory Linguists
Our translations are handled by subject-matter experts with backgrounds in regulatory affairs, legal medicine, and public sector documentation.
With Sesen, regulatory and government clients can trust that every translation is accurate, compliant, and ready for submission or publication.
Secure Technology. Human Precision.
Sesen combines advanced translation technology with expert human linguists to deliver efficient, secure, and compliant language solutions for regulatory and government clients.
Secure TMS Infrastructure
Our cloud-based Translation Management System (TMS) is hosted on Amazon Web Services (AWS), leveraging its robust security architecture, encryption protocols, and data redundancy to protect sensitive government and regulatory content.
Translation Memory & Terminology Management
We utilize dynamic translation memory and centralized terminology databases to enhance consistency, reduce turnaround times, and support controlled vocabulary compliance across submissions.
MTPE for Internal or High-Volume Content
Where appropriate, Machine Translation with Post-Editing (MTPE) is available for internal documentation or large-scale content that does not require certified translation—always reviewed by trained linguists to meet quality thresholds.
Secure Client Portals with Audit Trails
Clients gain access to a dedicated portal for file exchange, real-time project tracking, and version control, with complete audit trails for transparency and regulatory accountability.
eCTD & Submission Platform Integration
Seamless compatibility with electronic Common Technical Document (eCTD) structures and other submission formats ensures accurate formatting and faster regulatory processing.
Sesen’s technology stack is purpose-built to support the complex needs of regulatory translation—without compromising quality, security, or compliance.
Confidential by Design. Secure by Default.
Sesen implements stringent data protection protocols to safeguard sensitive government and regulatory content throughout the translation lifecycle. Our security infrastructure is designed to meet the confidentiality, integrity, and compliance expectations of public sector and life sciences clients.
End-to-End Encryption
All data transmissions and stored content are protected using industry-standard encryption protocols (TLS 1.2+ for data in transit, AES-256 for data at rest).
Strict Access Controls and NDAs
Project teams operate under binding non-disclosure agreements (NDAs), with role-based access control (RBAC) and secure authentication for all personnel and systems.
Secure File Handling Procedures
Files are managed through encrypted platforms with traceable workflows and optional document expiration settings to limit long-term exposure.
Global Data Privacy Compliance
Our operations are fully aligned with GDPR, HIPAA, and other regional data protection regulations to ensure legal and ethical handling of personal health and regulatory information.
At Sesen, data security is embedded in every process—because your confidential documents demand nothing less.
Proven Experience in High-Stakes Environments
Sesen has a strong track record of supporting government and regulatory clients with mission-critical translation services across global health and compliance initiatives.
Multilingual Public Health Campaigns During a Pandemic
Sesen partnered with national and regional health agencies to translate time-sensitive public health advisories, vaccination guidance, and crisis communication materials into over 30 languages. Our rapid-response linguist teams enabled real-time dissemination of accurate information to diverse populations during evolving public health emergencies.
Regulatory Submissions for Expedited Global Drug Approval
A leading pharmaceutical client engaged Sesen to translate a full suite of regulatory documents—including INDs, CTDs, and labeling—for simultaneous submission to health authorities in the U.S., EU, and Asia-Pacific regions. Our expert regulatory linguists and harmonized workflows helped reduce turnaround times and accelerate market authorization across jurisdictions.
These engagements highlight Sesen’s capacity to deliver high-quality, compliant translations under compressed timelines and across multilingual regulatory landscapes.
Why Sesen Is the Right Partner for Regulatory and Government Translation
Sesen is uniquely positioned to support the complex linguistic demands of regulatory authorities and government agencies operating in the life sciences sector.
Life Sciences Expertise
We specialize exclusively in regulated content—ranging from clinical trial documentation and regulatory submissions to public health communication—ensuring accuracy, terminology consistency, and compliance with industry standards.
Trusted by Government Entities
Our proven track record includes successful collaborations with public health institutions, regulatory bodies, and international organizations requiring high-stakes, multilingual deliverables.
Scalable and Time-Critical Capabilities
From routine filings to urgent response initiatives, our scalable workflows and global linguist network allow us to handle high-volume projects with compressed timelines—without compromising quality or security.
Regulatory-Focused Project Management
Each project is led by a dedicated manager with experience in regulatory translation workflows, eCTD structuring, and submission-readiness, ensuring seamless communication, on-time delivery, and full transparency.
With Sesen, regulatory and government clients gain a reliable, security-focused partner equipped to navigate multilingual compliance at scale.
