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.

C3 Summit 2024 - Princeton

Event

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 commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session ...

C3 Summit 2024 - Princeton
Webinar

Lessons Learned from SCMS Deployments in Global Medical Device Documentation

Transitioning to modular content using a Structured Content Management System (SCMS) has the potential to transform medical device documentation by streamlining authoring and automating content updates and publishing. For a truly successful implementation, however, early planning ...
Webinar

LifeSci Talks | Measuring What Matters: Modernizing Clinical Outcome Assessments with Patient-Centric Approaches

In this episode of LifeSci Talks, TransPerfect’s Global Practice Leader Mark Wade sits down with Dr. Karl McEvoy, VP of eCOA and Patient Technology at YPrime, to discuss the importance of embracing technology in clinical research to reduce the patient burden. The two cover ...
Blog

7 Essential Steps to Reach Global Audiences with Website Localization Services for Life Sciences Organizations

Website Localization for Life Sciences Organizations Means Greater Global ReachLife sciences organizations are under increasing pressure to connect with global audiences. With 65% of internet users preferring websites in their native language and 40% refusing to buy from...
Guide

Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

Pharmacovigilance professionals face an escalating challenge: data overload. From AI-powered transcription and case triage to automated literature translation, insights from the World Drug Safety Congress 2024 showcased practical solutions for streamlining workflows and reducing ...
Blog

Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

IntroductionIn the pharmacovigilance space, the overwhelming trend in the current landscape is data overload. Increasingly unmanageable volumes of information pose a core challenge for today’s pharmacovigilance professionals. While digital transformation and new technologies...
Webinar

LifeSci Talks | Effective Rater Training: A Critical but Overlooked Part of COA Administration

In this episode of LifeSci Talks, TransPerfect Life Sciences’ Global Practice Leader Mark Wade sits down with Kelly Dumais PhD, Director of eCOA Science at Clario to discuss the significance rater training plays in standardizing the administration and scoring of clinical scales. ...

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