Precision-Driven Translations for Global Pharmaceutical Labeling
In today’s global pharmaceutical market, accurate drug labeling and packaging translation services are essential for achieving regulatory compliance, ensuring patient safety, and expediting product approvals. From blister packs and patient leaflets to QRD templates and Structured Product Labeling (SPL), even minor translation errors can result in costly product recalls, delayed market entry, or regulatory noncompliance.
Sesen specializes exclusively in life sciences translation, offering deep regulatory expertise across FDA, EMA, Health Canada, and PMDA jurisdictions. Our dedicated linguists combine subject-matter knowledge with native language fluency to deliver precise, context-aware translations that align with health authority standards. Whether for clinical trial packaging or commercial drug labeling, Sesen ensures consistency, clarity, and compliance—every time.
End-to-End Translation Coverage for All Labeling and Packaging Components
Sesen delivers specialized drug labeling and packaging translation services to help pharmaceutical companies navigate multilingual compliance across all target markets. Below are the core content types we translate:
Primary and Secondary Packaging
Sesen translates content for cartons, blister packs, sachets, vials, ampoules, and tubes, ensuring regulatory accuracy, language clarity, and layout consistency across all packaging tiers.
Inner and Outer Labels
We localize both immediate container and external packaging labels, ensuring they meet global regulatory standards and support error-free usage and product identification in any market.
Patient Information Leaflets (PIL)
Our native-speaking linguists translate PILs to enhance patient understanding while aligning with EMA QRD guidance and local readability regulations. Sesen ensures content is both compliant and user-friendly.
Drug Inserts / Prescribing Information
Sesen translates product inserts and prescribing information for healthcare professionals, including dosage, contraindications, side effects, and pharmacological details—optimized for FDA, EMA, and regional agency formats.
Summary of Product Characteristics (SmPC)
We provide SmPC translations structured according to EMA templates and national guidelines to support drug registration, renewals, and multilingual product launches across Europe.
Medication Guides
Sesen prepares patient-facing medication guides with a focus on regulatory compliance and clarity, covering drug usage, risks, and safety instructions in accordance with FDA or local health agency guidelines.
Regulatory Labeling Documentation
From FDA Structured Product Labeling (SPL) to PMDA and Health Canada requirements, we support global regulatory content translation using validated processes and terminology management tools.
Barcodes and Serialization Content
We handle translations for variable data and traceability elements—aligned with GS1 standards and local serialization mandates for anti-counterfeiting and supply chain transparency.
Tamper-Evident and Safety Texts
Sesen ensures the precise translation of tamper-evident seals, warning labels, and critical safety content, validated through multi-stage linguistic review to eliminate risk in global packaging.
Regulatory-Grade Quality Assurance, Built for Life Sciences
Sesen applies a rigorous, ISO-certified quality assurance process tailored to the demands of drug labeling and packaging translation—where accuracy, consistency, and compliance are non-negotiable. Our end-to-end QA workflow is engineered to meet the highest regulatory and linguistic standards across global markets.
Specialized Linguist Selection
We assign native-speaking linguists with demonstrated expertise in pharmaceuticals and regulatory affairs. Each linguist is vetted based on therapeutic area knowledge, regulatory terminology fluency, and prior experience with labeling content.
ISO 17100 & ISO 9001:2015 Certified Workflows
All Sesen translation projects follow standardized quality management protocols under ISO 17100 (translation services) and ISO 9001:2015 (quality management systems), ensuring repeatable excellence and full auditability.
Independent Linguistic Review & In-Country Validation
Every translation undergoes a second-pass review by an independent medical linguist. For market-critical content, we provide in-country validation by local regulatory experts to align with regional health authority expectations.
Regulatory Formatting & Layout Checks
Sesen integrates multilingual desktop publishing (DTP) and formatting validation into our process. We ensure that translated content fits correctly into product packaging layouts, QRD templates, and SPL structures—without altering the original meaning.
Native-Speaking Medical Reviewers
We engage medical professionals fluent in the target language to review high-risk materials, such as prescribing information, safety warnings, and PILs—providing an extra layer of content verification.
Back Translation & Reconciliation (When Required)
For sensitive or high-stakes submissions, Sesen offers back translation with reconciliation, enabling clients to compare source and target content line-by-line to confirm accuracy for health authority audits.
This quality framework helps Sesen clients avoid regulatory setbacks, reduce internal review time, and accelerate product approvals across multilingual markets.
Multilingual Packaging Support That Goes Beyond Translation
Successful global drug launches demand more than just accurate translations—they require flawless integration of multilingual content into packaging design. Sesen delivers full-spectrum multilingual packaging support to ensure translated content is not only linguistically correct, but also technically and visually aligned with regulatory and production requirements.
Typesetting and Multilingual Desktop Publishing (DTP)
Sesen provides professional multilingual DTP services to ensure translated text fits seamlessly into complex pharmaceutical layouts—including cartons, labels, and inserts—without compromising design integrity or legibility.
Font and Character Set Verification
We validate all fonts, special characters, and non-Latin scripts (e.g., Chinese, Arabic, Cyrillic) to guarantee compatibility with print systems and prevent rendering issues that could cause regulatory or production delays.
Artwork Review and Regulatory Layout Alignment
Our team reviews translated artwork files to ensure correct placement of regulatory content, alignment with QRD and SPL formatting standards, and adherence to region-specific packaging rules.
Proofing on Print-Ready Packaging Files
Before final approval, Sesen conducts meticulous linguistic and layout proofing on print-ready files (PDF, AI, InDesign, etc.) to catch any formatting inconsistencies, line-break issues, or truncated text.
Coordination with Labeling Teams and Packaging Vendors
We collaborate directly with your internal labeling teams, regulatory affairs, and external design vendors to streamline implementation, minimize rework, and keep packaging timelines on track.
By offering turnkey support from translation to press-ready delivery, Sesen ensures your multilingual drug packaging meets both regulatory expectations and production specifications—across every market you serve.
Why Leading Pharma Companies Choose Sesen
Sesen is a trusted partner for drug labeling and packaging translation services, offering unmatched domain expertise, speed, and reliability. Our focused approach and proven delivery model help pharmaceutical and biotech companies bring products to global markets faster—with full regulatory confidence.
100% Life Sciences Focus
Unlike generalist agencies, Sesen is dedicated exclusively to the life sciences industry, enabling us to deliver linguistically accurate, compliant translations backed by deep subject-matter knowledge across therapeutic areas and regulatory frameworks.
Proven Track Record with Top Pharma and Biotech Clients
Sesen supports global labeling and packaging initiatives for leading pharmaceutical and biotechnology companies, from clinical development through commercialization. Our portfolio spans submissions to the FDA, EMA, PMDA, and Health Canada.
Dedicated Project Manager for Labeling & Packaging
Each project is managed by a dedicated life sciences expert who coordinates linguists, DTP specialists, and QA teams—ensuring alignment with your regulatory, medical writing, and packaging workflows.
Accelerated Turnaround for Global Submissions
We offer fast, scalable translation support to meet tight regulatory timelines, whether you’re preparing initial MAAs, label updates, or global launch rollouts. Priority and rush services are available without compromising quality.
Transparent Communication & Flexible Review Cycles
Sesen provides weekly status updates, detailed progress tracking, and customizable review schedules. We work collaboratively with your internal stakeholders to streamline feedback, minimize bottlenecks, and maintain full visibility.
With Sesen, you get more than translation—you gain a strategic partner in global pharmaceutical compliance.
Real-World Results: Multilingual Labeling Success for a Global Pharma Leader
A top 10 global pharmaceutical company partnered with Sesen to support a time-sensitive multilingual labeling project involving 24 languages across EU, APAC, and LATAM markets. The scope included translation and DTP for patient information leaflets (PILs), outer packaging, and regulatory inserts, all aligned with EMA QRD templates and local health authority requirements.
Sesen’s impact:
- Reduced internal review cycles by 35% through centralized terminology management and in-country validation
- Achieved 100% on-time delivery across all language batches to meet regulatory submission deadlines
- Streamlined layout approvals through integrated DTP and compliance proofing
- Enabled faster market access and improved coordination between regional teams and packaging vendors
By combining life sciences translation expertise with end-to-end project management, Sesen helped the client accelerate their product launch while maintaining full regulatory compliance.
