Regulatory & Compliance in Life Sciences
The risks of translation errors in regulatory content are substantial, potentially resulting in delayed approvals, product recalls, or non-compliance penalties. Whether it’s the mistranslation of dosage instructions in a patient leaflet or terminology inconsistencies in a Module 1 submission, the margin for error is zero.
Accurate, high-quality, and fast translation is essential to achieving global regulatory milestones. Life sciences companies must navigate the linguistic and technical complexity of international compliance while managing large volumes of documentation under tight deadlines.
Sesen’s regulatory translation services are designed specifically for this high-stakes environment, combining domain-specific human expertise with AI-powered tools to ensure consistency, efficiency, and full compliance with international standards.
The Role of AI in Regulatory & Compliance Translation
AI is transforming how life sciences companies manage regulatory and compliance translation at scale. By automating repetitive processes and supporting linguists with real-time language intelligence, AI accelerates document processing, improves consistency, and reduces time-to-submission.
Advanced Natural Language Processing (NLP) models can classify, extract, and align regulatory content with high precision—supporting faster localization of global regulatory documents without compromising accuracy. AI also ensures terminological consistency across thousands of pages, a critical requirement for meeting EMA, FDA, PMDA, and NMPA expectations.
Common Use Cases:
Regulatory Dossier Compilation
AI accelerates the preparation and translation of multilingual eCTD modules by reusing aligned content and enforcing structure compliance.
Labeling and Product Information
Seamless translation of SPCs, PILs, SmPCs, and IFUs with AI-assisted terminology control and change tracking.
Pharmacovigilance Reports
AI improves turnaround time for DSURs, PSURs, and ICSRs, helping teams meet global safety reporting timelines.
Clinical Trial Documentation
NLP models support rapid localization of IRB submissions, ICFs, study protocols, and patient-facing materials—ensuring compliance and participant understanding.
Sesen’s AI-powered translation workflows combine machine learning with expert human oversight to support regulatory teams in managing complexity, reducing costs, and accelerating global market access.
Sesen’s AI Capabilities for Regulatory Translation
Sesen combines deep regulatory expertise with proprietary AI technologies to deliver fast, accurate, and scalable translation solutions tailored to the life sciences sector.
At the core of our AI strategy is SesenGPT, a purpose-built large language model (LLM) trained exclusively on life sciences and regulatory content. Unlike general-purpose AI, SesenGPT is domain-tuned to understand the structure, terminology, and compliance requirements of documents such as SmPCs, IFUs, clinical trial protocols, and regulatory submissions.
Key Capabilities:
Hybrid Translation Workflow
Sesen integrates domain-specific AI with professional human linguists to deliver high-accuracy translations that meet global regulatory standards. Our hybrid model ensures speed without sacrificing quality or compliance integrity.
MTPE with Regulatory Experts
We apply Machine Translation Post-Editing (MTPE) using experienced linguists and regulatory subject matter experts. This ensures content is linguistically accurate, scientifically precise, and submission-ready.
Custom AI Models Trained on Regulatory Content
Sesen can fine-tune AI engines using client-specific regulatory datasets, ensuring the translation output aligns with internal style guides, terminology, and prior submissions.
AI-Enhanced Translation Memory and Terminology Management
Our AI-powered Translation Memory (TM) and termbase management systems improve version control, enforce consistency, and adapt terminology dynamically across regions and product lines.
This intelligent integration of human and AI capabilities enables Sesen to support complex, high-volume regulatory translation projects while meeting aggressive timelines and strict compliance demands.
Compliance with Industry Standards
Sesen’s regulatory translation services are built on a foundation of certified quality, data integrity, and global compliance. Our AI-enabled workflows meet the strictest industry and regulatory standards required by life sciences organizations.
We are fully certified to ISO 17100 (Translation Services), ISO 9001:2015 (Quality Management), and ISO 13485:2016 (Medical Devices), ensuring that every deliverable meets rigorous quality and traceability requirements.
Our content workflows are aligned with global regulatory expectations, including:
- EMA QRD templates for centralized EU submissions
- FDA labeling guidelines and submission protocols
- PMDA and NMPA language requirements for Asia-Pacific markets
We prioritize data privacy and security across all stages of project execution. Our systems and processes are compliant with:
- HIPAA (U.S. patient data protection)
- GDPR (EU data privacy regulation)
- 21 CFR Part 11 (electronic records and signatures)
Sesen’s AI-powered translation platform is hosted on AWS, leveraging enterprise-grade encryption, secure access controls, and full audit trails to protect sensitive regulatory content throughout the translation lifecycle.
AI Use Cases in Regulatory & Compliance Translation
AI plays a critical role in streamlining regulatory and compliance translation workflows across the life sciences industry. By automating repetitive tasks, supporting consistency, and accelerating turnaround times, AI enables regulatory teams to meet global submission requirements with greater efficiency and control—always paired with expert human translators to validate accuracy and compliance.
Multilingual Labeling Translation
AI supports the rapid translation and alignment of Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and Instructions for Use (IFUs) across multiple languages—ensuring consistency with QRD templates and region-specific requirements. All content is reviewed and refined by experienced medical translators to ensure regulatory accuracy.
eCTD Module Localization
AI accelerates the translation of electronic Common Technical Document (eCTD) modules, particularly Modules 1 (regional), 2 (summaries), and 5 (clinical study reports), by leveraging NLP for structure recognition, content extraction, and reuse across submissions. Expert linguists specializing in regulatory content perform post-editing and quality assurance to ensure submission readiness.
Pharmacovigilance and Safety Reporting
AI-powered translation enhances the speed and consistency of pharmacovigilance documentation, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and individual case safety reports (ICSRs), while maintaining compliance with EMA and FDA timelines. Human editors with pharmacovigilance expertise validate terminology and context.
Clinical Trial Documentation
From IRB submissions and investigator brochures to informed consent forms (ICFs) and study protocols, AI facilitates fast, compliant localization of high-volume clinical trial documents. Specialized medical translators ensure cultural appropriateness and regulatory alignment for each target market.
Regulatory Change Management and Version Control
AI aids in identifying and translating updated sections in labeling, safety, and registration documents. Integrated with Translation Memory and terminology databases, AI helps regulatory teams maintain consistency across product families and market updates. Final output is reviewed and approved by professional linguists with regulatory experience.
Sesen’s AI-enhanced translation solutions are designed for accuracy, scale, and compliance—delivering the speed of AI with the quality assurance of professional human translation.
Why Sesen?
Sesen is uniquely positioned at the intersection of AI innovation and regulatory translation excellence. Our solutions are purpose-built for life sciences organizations navigating the complex demands of global compliance and multilingual documentation.
Industry-Specific Regulatory Expertise
We specialize in regulatory translation across pharmaceuticals, biotechnology, and medical devices, with deep familiarity in EMA, FDA, PMDA, and NMPA requirements. Our linguists and subject matter experts are trained to handle critical documentation such as SmPCs, IFUs, clinical protocols, and safety reports with precision and compliance in mind.
AI-Enhanced Human Workflows
Our proprietary AI technology—combined with professional human translation—enables faster delivery, reduced costs, and higher consistency. Every project leverages AI for scalability, but final output is always reviewed by trained linguists to meet regulatory-grade standards.
In-House Linguistic QA and SME Review
We maintain a rigorous multi-step QA process, including in-house linguistic validation and review by regulatory subject matter experts, ensuring that all translations meet technical, scientific, and compliance expectations.
Dedicated Regulatory Project Management
Each client engagement is supported by a dedicated project manager with a background in regulatory affairs or life sciences localization. This ensures smooth communication, proactive risk management, and alignment with submission timelines.
Sesen delivers the speed of AI with the assurance of expert-led workflows, making us the trusted partner for regulatory translation in life sciences.
Let’s Talk About Your Next Regulatory Submission
Whether you’re preparing multilingual eCTD modules, updating IFUs, or translating pharmacovigilance reports, Sesen is ready to support your global regulatory strategy with precision and speed.
Our AI-powered workflows can integrate with leading life sciences platforms such as Veeva Vault, Oracle Argus, and MasterControl, ensuring efficient document handling and version control across your submission lifecycle.
Speak with our team to explore how Sesen can accelerate your next regulatory submission while maintaining full compliance.
