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

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.

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.

News and Press Releases

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

Trial Interactive Customer Summit, OpTImize

Event

Sheraton Times Square 811 7th Avenue New York, NY 10019 ...

Trial Interactive Customer Summit, OpTImize
Event

AI & MT "Ask an Expert" Office Hours": PV and Safety

| ...
Event

AI and MT "Ask an Expert" Office Hours": Clinical and Regulatory Documents and Content

| ...
Event

AI & MT "Ask an Expert" Office Hours: Real World Data

| ...
Event

Engaging Patient Communities: A Pathway to Clinical Trial Success

| ...
Guide

Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from ...
White Paper

An Overview of Generative AI and Machine Translation for Life Sciences

Global life sciences companies are realizing the potential artificial intelligence (AI) and machine learning (ML) has to drive efficiency in content and translation management. To capitalize on this, organizations need to identify the right solutions. Discover important ...

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

How did you hear about us?
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.