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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Ready to Speed Up Timelines, Ensure Quality, and Control Costs?

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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.

Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities

Blog

The European Commission’s proposed Biotech Act introduces changes that could reshape how clinical trials are approved and managed across the EU. While the broader package spans multiple areas of the health ecosystem, proposed updates to the EU Clinical Trial Regulation (EU CTR) stand out for their potential to address long-standing operational challenges including lengthy timelines, limited flexibility in submissions, and fragmented processes across member states. ...

Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities
Checklist

A Checklist for eCOA Solution Deployment: Best Practices and Considerations

Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the ...
Success Stories

Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions

This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for ...
White Paper

Successful English Build & Language Migration

Over the past decade, the global clinical trial landscape has changed drastically. A surge in technological innovation, including wearable devices, patient portals, and apps, has modernized how clinical data is collected and managed. With pen and paper becoming obsolete in the ...
Blog

Why 75% of Medical Device Manufacturers Are Disappointed with Their AI Results

The Gap "The results we're seeing from AI are only as good as the data and structure we put behind it. Most manufacturers haven't done that work yet." — Marc Miller, Division President, TransPerfect Medical DeviceArtificial intelligence has arrived in medical device...
Blog

Metadata In, Metadata Out: Reducing RIM Submission Rework with In-System Translation

Pharmaceutical companies spend billions and take years to bring therapies to market. Then many risk it all on a translation process managed with spreadsheets, email chains, and blind faith. Every label update, every safety amendment, every regulatory change notice must be...
Blog

AI Content Creation and Maintenance in Medical Information: Ending the Content Whack-a-Mole

For many medical information (MI) teams, content maintenance can often feel like a game of whack-a-mole.Update one answer, three more pop up. Fix a regional version, and another channel drifts out of sync. Add a new piece of literature, and suddenly every approved response...