Speed Up Regulatory Approvals with Multilingual IMP Labeling Services

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

Let's Talk
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

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.

Contact Us

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?

Learn More ›

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.

20230124-lifesciences-resize-v3_0022_400x160px-hologic_logo.png
untitled_design_4.png
20230124-lifesciences-resize-v3_0016_400x160px-bayer_logo.png
20230124-lifesciences-resize-v3_0015_400x160px-merck_logo.png

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

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

News and Press Releases

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

Regulatory Considerations for Paper COA Translations | What You Need to Know

Blog

Collecting data for a global clinical trial on paper COAs or managing a mixed-mode study that combines both paper and electronic formats means satisfying multiple regulatory bodies before a single patient enrolls. None of these entities operate on the same timeline or answer to each other. While paper instruments might seem more flexible to deploy because they don’t require electronic implementation, there are still process considerations based on the instrument’s ...

Regulatory Considerations for Paper COA Translations | What You Need to Know
Webinar

XTalks | eCOA: Has It Lived Up to the Promise? A Realistic Assessment for Today's Trials

Despite two decades of technological advancement, the debate between paper and electronic clinical outcome assessments (eCOA) remains unresolved. This webinar revisits the assumptions that continue to shape data collection strategies and examines whether current practice reflects ...
Webinar

SSCPs Are Not Labeling: Compliant AI Processes for Reduced Cost & Turnaround

In this fireside chat, TransPerfect Medical Device's President Marc Miller sits down with Dr. Keith Morel, VP of Regulatory Compliance at Qserve, to unpack a critical question facing medical device manufacturers under MDR: can you reduce the translation review process for ...
Success Stories

Top 10 Pharma Company Overhauls Global COA Program,Cutting Costs by 33% and Errors to Near Zero

Inconsistent standards, stretched timelines, and limited visibility were straining a top 10 pharma company's COA program. Discover how TransPerfect Life Sciences' centralization strategy delivered 99.7% accuracy, 40% less PM oversight, and 33% cost savings across the ...
Blog

Four Years In: What the EU Clinical Trial Regulation Has (and Hasn't) Delivered

When the EU Clinical Trial Regulation (EU CTR No 536/2014) went live for new submissions on January 31, 2022, it promised to transform how clinical trials are authorized and conducted across Europe: a single submission, one decision, and harmonized oversight. Four years in,...
Webinar

How to Make Your Academy Succeed at Global Scale—Lessons Learned on What Works and What Doesn’t

Most life sciences and MedTech companies launch a corporate academy with strong strategic intent, whether that’s executive sponsorship, a named platform, a dedicated budget, or a curriculum mapped to business goals. After launch, however, these same organizations all too often ...
Webinar

IMP Labeling Workflows That Reduce Relabeling Risk and Start-Up Delays

Investigational medicinal product (IMP) labeling sits at the heart of clinical trial supply, impacting departments across pharmaceutical organizations, from clinical operations and regulatory affairs to quality assurance and beyond. When labeling activities are managed across ...