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.

Trusted by Life Sciences Organizations Big and Small

Join TransPerfect's community of over 1,000 life sciences organizations, including pharma, biotech, CROs, IRBs, and agencies.

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News and Press Releases

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

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Reddit Stories: AI Failures in Clinical Trials
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