For pharmaceutical and biotech companies, and for the CROs and regulatory consultancies acting on their behalf, regulatory translation is frequently a legal requirement for commercialization.
Without the required approved language versions, authorization and commercialization can be delayed or prevented in relevant markets.
This makes regulatory translation fundamentally different from conventional translation. Every word needs to work within a defined regulatory, scientific and linguistic context, while remaining aligned with the source, approved terminology and applicable authority requirements.
When the same source content is translated into multiple languages, ambiguity or inconsistency in the source can multiply across the submission. Questions from regulators, approval delays and rework can follow, potentially affecting several markets at a time. At the sharper end, stock can be held at site pharmacy level until compliant labeling is in place.
IQVIA Language Solutions combines regulatory knowledge with specialist language capabilities to help identify these risks earlier, supported by the scale of our in-house linguist pool and our team’s scientific and medical regulatory expertise.
Translation support can include:
We support the translation and production of:
Including:
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IQVIA Language Solutions brings regulatory, linguistic and technology capabilities together across the submission lifecycle. Our services are designed to connect translation with the wider regulatory process, rather than treating language as a separate activity.
Regulatory translation works best when language requirements are considered as part of the wider regulatory strategy.
Our capabilities include:
IQVIA Language Solutions supports marketing authorization translation and preparation of multilingual submission content, combining regulatory expertise with specialist language capabilities.
For the EMA centralized procedure specifically, following a positive CHMP opinion at Day 210, the marketing authorization holder must submit translated product information at Day 215. This allows just five calendar days to produce 24 legally binding language versions, making an integrated and specialized approach especially important.
Changes to a product, from dosage and safety wording to manufacturing changes and expansion into new markets, can trigger regulated update requirements. Change a word, and that change needs approval in every market. For a product that stays on the market for 20 years, that is 20 years of regulated change.
As products move through their lifecycle, IQVIA Language Solutions helps manage the associated multilingual change process across markets, including:
Clinical and investigational product labeling requirements can vary between countries and regulatory authorities. Our specialists support the development and management of multilingual IMP labeling across global clinical programs, helping sponsors address market-specific requirements while maintaining consistency across the wider study.
Our capabilities include:
The EU Clinical Trials Regulation is one example of the complex, authority-specific requirements that can affect IMP labeling. Under Article 69 of Regulation (EU) No 536/2014, each Member State determines the language requirements for labeling for trials conducted on its territory, and multilingual labeling is permitted.
This means EU labeling requirements need to be assessed on a per-country basis. Similar regulatory considerations can arise across other markets, making an understanding of the local and authority-specific requirements an important part of managing global clinical programs.
Turn approved regulatory content into production-ready artwork for multiple markets, with support throughout the artwork development, adaptation and review process.
Capabilities include:
Not every regulatory project requires the same level of translation, review or validation. The appropriate process can depend on the document, market and submission requirements. In some cases, specific regulatory authorities or procedures may require particular levels of review, certification or supporting documentation.
We can provide individual language services or combine them into integrated workflows, helping you apply the right level of linguistic and regulatory control to each project.
Services include:
These capabilities can be integrated into broader regulatory workflows, helping maintain consistency and traceability throughout the process.
Our expertise includes:
IQVIA Language Solutions provides regulatory language and translation support across all major global markets and regulatory frameworks.
Regulatory requirements vary by market, procedure and document type. We can advise and create an appropriate workflow for any combination of requirements.
Common risks include ambiguity in the English source being replicated across multiple languages, inconsistent terminology, missed authority-specific requirements and insufficient documentation.
The translation itself is only part of the process. The supporting evidence and controls are also important for demonstrating how the work was completed.
Turnaround times depend on factors including document volume and complexity, the number of languages, the regulatory procedure, any fixed authority deadline and whether additional services such as back-translation, in-country review or certification are required.
IQVIA Language Solutions can assess your requirements and establish an appropriate workflow and timeline for your submission.
IQVIA Language Solutions provides regulatory language and translation support across all major markets, including requirements associated with the EMA, FDA, MHRA, Swissmedic, Health Canada, PMDA, NMPA, TGA and ANVISA, alongside relevant regulatory frameworks and standards.
Specific requirements depend on the market, procedure and document type.
IQVIA Language Solutions implements AI where it adds value to our processes and solutions. For more on when and how we use AI, visit our Language Technology page.
Language solutions for life science, by life science
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