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

Before a trial can start in any country, investigational medicinal product (IMP) or auxiliary medicinal product (AMP) labels must receive approval from a regulatory authority, leaving little room for error. Sponsors must navigate the complexity of evolving regulations while avoiding inadvertent omissions and translation errors or oversights to prevent significant delays. TransPerfect Life Sciences simplifies the complexity of translations and regulatory review with global IMP labeling solutions that ensure label quality, compliance, and timelines to avoid start-up delays in more than 200 languages.

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.

eCOA Vendor Localization Best Practices Checklist

Checklist

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up. It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance, and configurability. The investment of both time and money, not to mention protecting and upholding the integrity of the data collected, is critical when seeking regulatory approval and confirming ...

eCOA Vendor Localization Best Practices Checklist
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Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up.  It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance...
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