Speed Up Regulatory Approvals with Multilingual IMP Labeling Services

Quality-First Mentality, flexible and reliable support you can trust

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Scale and complete regulatory reviews and translations for any country or any label type using our ISO-certified process and 21 CFR Part 11-compliant technology

Scale and complete regulatory reviews and translations for any country or any label type using our ISO-certified process and 21 CFR Part 11-compliant technology

Simplify IMP Labeling Workflows with TransPort

Manage, centralize, and streamline your label workflow and content development to automate manual label approvals with TransPerfect Life Sciences’ 21 CFR Part 11-compliant and validated software, TransPort.

Centralized Document Management

With specialized workflows and instances for clinical supplies in both document management systems (DMS) and component content management systems (CCMS), our technology-backed workflows combined with our dedicated regulatory and project management teams ensure faster time-to-market, higher accuracy, and overall cost savings.

Regulatory Review/Label Validation & Consulting

With 30+ years of experience, we have helped global pharmaceutical companies and CROs integrate our IMP labeling services into established critical processes for content creation, approval, translation, and delivery of country-compliant labels for clinical trials as well as for managed access, expanded access, and compassionate user programs.

Fast Label Creation—In Any Language

We help with creating multilingual IMP labels that follow ISO-certified procedures, including a multi-step translation process with back translation and reconciliation. We also create your English label(s) based on your protocol.

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Benefits of TransPerfect Life Sciences’ IMP Labeling Service

100 %

Label compliance

50 %

Faster timelines

98.5 %

First-time approval

250 k

Unique labels processed/year

Is Your Clinical Supply Labeling Strategy Ready for EU CTR?

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Compliant and Fast IMP labels you can trust

Take your timelines from months to weeks and weeks to days with TransPerfect Life Sciences. Our IMP labeling service is a one-stop shop for all of your multilingual label creation needs.

News and Press Releases

Our industry experts have in-depth understanding of the challenges, requirements, and goals for life sciences organizations.

Accelerating Pharma Labeling with Intelligent, Compliant Content

White Paper

Juggling multilingual labels across varying regions and products? Managing the updates and complying with local health authorities' requirements can be a challenge for global pharmaceutical companies, who are facing increasing pressure to streamline labelling processes and digitize labels. This white paper details how a unified eLabeling solution can eliminate duplication, improve accuracy, and deliver measurable ROI. ...

Accelerating Pharma Labeling with Intelligent, Compliant Content
Blog

Health Canada's Transition to XML: What Regulatory Teams Need to Know

In a continued push toward modernization and transparency, Health Canada has entered the next phase of its digital transformation with a mandate requiring the use of advanced extensible markup language product monograph (XML PM) files. This change builds on earlier...
Webinar

LifeSci Talks COA Series | Balancing Innovation and Integrity: AI’s Place in Patient-Focused Research

Artificial intelligence is redefining what’s possible across the clinical development lifecycle, but with rapid innovation comes the need for thoughtful oversight. In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with ...
White Paper

Web Localization Playbook for Life Sciences

The life sciences industry relies on websites to connect with patients, sites, and global audiences. Whether you're launching a patient recruitment campaign or managing an international healthcare marketing initiative, localization ensures your message is not just understood ...
Webinar

Rewriting the Rules of Informed Consent Development with AI

Regardless of the market a clinical trial is being conducted in, getting locally approved informed consent forms (ICFs) consume as much as 12% of a clinical trial budget before it even begins. Each ICF must be clear and delicately balance local regulations and patient ...
Guide

Multilingual IMP Labeling Quick Guide

Meet global regulatory expectations the first time with these efficient, cost-effective, and compliant product labeling solutions and considerations. ...
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