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Ensuring Regulatory Accuracy in Multilingual Multimedia Content
Audiovisual compliance translation refers to the specialized adaptation of multimedia content—such as training videos, eLearning modules, and patient-facing animations—to meet the regulatory, linguistic, and cultural requirements of specific target markets. Unlike general subtitling or dubbing, compliance-grade localization requires deep domain knowledge to ensure that terminology, phrasing, and on-screen content align precisely with country-specific guidelines and industry standards.
In the life sciences sector, organizations such as pharmaceutical companies, biotechnology firms, medical device manufacturers, CROs, and healthcare providers rely heavily on video content for clinical training, product education, and regulatory communication. These materials must be not only linguistically accurate but also compliant with the expectations of authorities like the FDA, EMA, PMDA, and local IRBs.
Sesen’s audiovisual compliance translation services are designed specifically for high-risk and highly regulated environments—where even minor errors in translated multimedia can result in audit findings, market delays, or patient safety risks.
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Why Accurate Audiovisual Compliance Translation Matters
In life sciences, multimedia content used for training, patient education, and promotional purposes is subject to strict scrutiny by global regulatory bodies such as the FDA (U.S.), EMA (Europe), PMDA (Japan), and NMPA/CFDA (China). These agencies expect all localized content to retain the original message with complete accuracy—both linguistically and contextually.
A single mistranslation in audiovisual materials—whether a subtitle error in a clinical training video or a voiceover misstatement in a patient instruction clip—can result in compliance violations, product recalls, or compromised patient safety. The stakes are especially high when content involves adverse event procedures, dosage guidelines, or medical device operation.
In addition, translated content must align with approved corporate glossaries, SOP documentation, and regulatory submission language to ensure consistency and auditability. Compliance translation goes beyond word-for-word conversion—it involves regulatory insight, terminology management, and rigorous quality control to ensure that all multimedia assets meet local and international standards.
Sesen’s specialized workflows are designed to address these challenges—delivering multimedia translations that are audit-ready, terminologically consistent, and compliant with the latest global health regulations.
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Use Cases for Audiovisual Compliance Translation in Life Sciences
Sesen provides audiovisual compliance translation for a wide range of multimedia assets used throughout the life sciences industry. These materials are critical for regulatory training, patient safety, market authorization, and internal compliance—and must be accurately localized to meet global requirements:
Clinical Trial Training Videos
Accurate translation of protocol overviews, safety procedures, and informed consent walkthroughs for site staff and investigators.
Investigator Meeting Recordings
Multilingual subtitling and voiceover for recorded sponsor meetings to ensure consistency and understanding across global research teams.
Patient-Facing Educational Animations
Culturally adapted, compliant voiceovers and subtitles for videos that explain treatment procedures, device usage, or clinical participation.
Promotional Content Subject to Local Regulations
Localization of branded videos and advertisements to meet in-country medical advertising laws and approval standards.
eLearning Modules for HCPs and Field Teams
Translation and compliance review of interactive training modules covering product use, safety protocols, and clinical best practices.
Internal SOP and Onboarding Videos
Translation and quality review of corporate training content to align with internal policies, SOPs, and audit-readiness requirements.
Each content type demands not only linguistic fluency but also an in-depth understanding of regulatory and cultural nuances—making Sesen a trusted partner for life sciences companies operating on a global scale.
Our Capabilities
Sesen offers end-to-end audiovisual compliance translation services tailored to the regulatory and linguistic demands of the life sciences industry:
Subtitle Translation with Regulatory QA
Accurate subtitle localization with multi-step linguistic and regulatory review to ensure terminology compliance and on-screen clarity.
Multilingual Voiceovers with Terminology Alignment
Professionally recorded voiceovers by native-speaking voice talents, aligned with approved glossaries and regional regulatory expectations.
Transcription & Timecoding with Audit-Ready Documentation
Precise transcription and timecoding services to support compliance records, multilingual accessibility, and traceability requirements.
Script Adaptation for Cultural and Regulatory Fit
Expert adaptation of video scripts to meet both cultural norms and in-market regulatory requirements, without compromising original intent.
In-Context Review to Ensure Subtitle/Audio Accuracy on Screen
Final review of translated subtitles and voiceovers in video context to validate synchronization, readability, and technical correctness.
Secure Workflow with ISO 17100 and ISO 13485:2016 Compliance
Confidential handling of all audiovisual materials within a secure, ISO-certified environment, including NDA coverage and role-based access.
Sesen’s capabilities are purpose-built to support compliance-driven multimedia localization, ensuring your video assets are accurate, auditable, and globally deployable.
Compliance-Driven Workflow
Sesen’s audiovisual translation workflow is purpose-built to meet the stringent compliance and quality assurance requirements of life sciences organizations. Each step is designed to minimize regulatory risk while maintaining linguistic and technical accuracy:
Content Ingestion and Risk Evaluation
We begin by reviewing source multimedia content to assess regulatory exposure, identify high-risk terminology, and define localization requirements by region.
Linguistic Validation with Compliance Terminology
Translations are aligned with client-approved glossaries, SOPs, and regulatory submission language to ensure accuracy and consistency with in-market standards.
Multistep Review: Linguistic, Technical, and Regulatory
Every deliverable undergoes a multi-layered QA process, including linguistic proofreading, technical review (timing/synchronization), and regulatory validation.
Output QA with Version Control
Final subtitled or voiceover-integrated videos are reviewed in context, versioned for traceability, and checked for format, playback, and terminology compliance.
Delivery with Full Audit Trail Documentation
All projects are delivered with supporting documentation, including language certificates, reviewer records, and change logs to support audits and inspections.
This structured, audit-ready workflow ensures your localized multimedia content is compliant, consistent, and deployment-ready across all target markets.
Why Sesen
Life sciences companies around the world trust Sesen for high-stakes audiovisual compliance translation. Our specialization, expertise, and secure infrastructure make us uniquely equipped to support your regulatory and localization goals:
Exclusive Focus on Life Sciences
We work solely with pharmaceutical, biotechnology, medical device, CRO, and healthcare organizations—bringing unmatched domain expertise to every project.
Native Linguists + Subject-Matter Experts
Our linguists are native professionals with deep knowledge of clinical, regulatory, and scientific content—ensuring both linguistic and technical precision.
Familiarity with Region-Specific Regulatory Nuances
From FDA and EMA to PMDA and NMPA, we understand the unique regulatory expectations in each target market and tailor multimedia localization accordingly.
Secure Platforms for Handling Sensitive Materials
All content is processed in ISO 17100- and ISO 13485-certified environments, with strict access controls, encryption protocols, and full NDA coverage.
Proven Track Record with Industry Leaders
Sesen has supported global multimedia compliance projects for top-tier pharma, biotech, and medtech companies—delivering results on time and within spec.
With Sesen, you gain a strategic localization partner who understands both the technical and regulatory demands of multilingual audiovisual content in life sciences.
Frequently Asked Questions
What regulations apply to audiovisual translation in life sciences?
Audiovisual content used in clinical, regulatory, and promotional contexts may be subject to oversight by agencies such as the FDA, EMA, PMDA, and NMPA. These authorities require that translated multimedia materials—such as training videos and patient education modules—are accurate, culturally appropriate, and compliant with approved terminology and labeling standards.
How is audiovisual compliance translation different from regular dubbing?
Compliance translation goes beyond linguistic conversion. It requires subject-matter expertise, regulatory knowledge, and rigorous QA to ensure that voiceovers and subtitles align with local laws, standard operating procedures (SOPs), and product labeling. Regular dubbing typically lacks this regulatory rigor and is not suitable for high-risk content in the life sciences sector.
Can you help adapt an English training video for multiple markets?
Yes. Sesen provides multilingual adaptation of training videos, including subtitle and voiceover translation, terminology harmonization, script modification for regulatory alignment, and in-context QA. We support simultaneous rollout across multiple languages and regions with full version control and documentation.
Do you provide audit documentation for each translation?
Absolutely. Every compliance translation project is delivered with audit-ready materials, including reviewer records, language certificates, tracked changes (if applicable), and finalized timestamped assets to support regulatory inspections or internal quality audits.
What languages and formats do you support?
Sesen supports audiovisual translation in over 150 languages and works with all major video formats, including MP4, MOV, AVI, and WMV. We also handle subtitle files (e.g., SRT, VTT, STL), and provide integrated voiceover and subtitling services for both linear and interactive video content.