Speed Up Regulatory Approvals with Multilingual IMP Labeling Services

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

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imp lableing

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.

Keeping Patients at the Heart of Clinical Trials

Webinar

Clinical trial patient recruitment continues to be challenging. Even with shifts to decentralize clinical trials and the addition of new vendors and technology, recruitment still is the primary cause of delays or discontinuation. What could we be missing? In this webinar, we’ll discuss the current state of clinical trials, historical challenges of recruitment, and new thinking to integrate human touch and improve retention. We will share frameworks and ...

Keeping Patients at the Heart of Clinical Trials
Webinar

LifeSci Talks COA Series | AI-Powered Innovations in Clinical Trials: Optimizing Every Step

Explore how artificial intelligence is rapidly changing the landscape of clinical trials, from discovering new therapies and complex calculations to protocol optimization. Discover how AI can generate study protocols, consent forms, and more, saving time and resources. Join us to ...
Guide

Translation and Cultural Adaptation of Clinical Outcome Assessments (COAs): Is Machine Translation a Viable Option?

As technology continues to advance and the need to expedite drug development increases, the applications of Machine Translation (MT) and Artificial Intelligence (AI) in the translation process should be further explored. The capabilities of iterative learning and feedback can ...
Blog

The Role of Artificial Intelligence (AI) in Clinical Outcome Assessments (COAs)

Written by Mark Wade, Global Practice Leader, COA SME. Abstract  Artificial Intelligence (AI) is the new frontier for content creation, reuse of language assets; saving time and effort in the curation of documentation. The widely adopted generative AI tools, such as ChatGPT...
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Takeda and Psyon games sought to improve ADHD awareness while improving quality of life for individuals navigating the diagnosis. Their goal was to roll out an accessible experience across multiple regions, languages, and cultures to help as many individuals as possible. Watch ...
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Five Essential Roles Artificial Intelligence Plays in Medical Writing

In the biotech and pharmaceutical industries, the importance of effective communication cannot be overstated. With a responsibility to accurately convey critical scientific findings, regulatory updates, and patient information1, the pressure is on medical writing teams to...
Event

C3 Summit 2023 - Princeton

Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to ...

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