The Translation Gaps Regulatory Teams Miss
Overview
For global pharmaceutical, biotechnology, and medical device companies, FDA submissions increasingly involve information collected, created, and reviewed across multiple languages, teams, systems, and locations. Translation is therefore not simply a language service performed before submission. It is part of the process of preparing information for regulatory review.
Most regulatory teams already have extensive processes for reviewing clinical data, documentation, formatting, and submission requirements. Translation can receive less attention, particularly when it is treated as a downstream activity.
That creates a potential gap.
A translation can be linguistically accurate and still introduce submission risk if content is missing, terminology is inconsistent, files are misaligned, regional language requirements are overlooked, or the workflow does not provide enough visibility and quality control.
As clinical programs become larger and more globally distributed, identifying these risks before submission becomes increasingly important.
Where Does Translation Risk Enter an FDA Submission?
Translation risk does not necessarily begin with a mistranslated sentence. It can enter much earlier, when source files are collected, prepared, assigned, updated, or transferred between teams.
A regulatory translation workflow may involve hundreds or thousands of files across multiple languages and document types. Some files may contain tables, figures, screenshots, annotations, scanned pages, or other content that is difficult to extract. Source documents may also change during the submission process.
When these variables are not controlled, problems can become difficult to identify by the time the translated content reaches final review. For regulatory teams, translation readiness therefore involves more than asking whether the English is accurate. It involves asking whether the entire multilingual workflow is complete, controlled, and traceable.
1. Untranslated Content Can Hide Inside Otherwise Complete Documents
One of the simplest translation risks is also one of the easiest to overlook: content that was never translated.
Regulatory documents can contain text within tables, figures, images, charts, screenshots, headers, footnotes, annotations, and other embedded elements. Depending on how source files are prepared and processed, this content may not be captured during standard text extraction.
The resulting document can appear complete while still containing untranslated information. A document-level review should therefore consider more than the primary text. Teams should determine whether embedded content, annotations, references, and other non-standard elements also require translation. Identifying these issues before linguistic work begins can help reduce last-minute corrections and additional review cycles.
2. Terminology Can Drift Across a Large Submission
Regulatory submissions often repeat the same clinical, technical, and safety terminology across multiple documents.
If terms are translated differently from one document to another, reviewers may have to determine whether different terms represent the same concept. In clinical and regulatory content, that ambiguity can create unnecessary questions and complicate review.
Terminology management helps address this risk.
A controlled glossary can establish approved terminology for recurring clinical, technical, product, and regulatory concepts. Translation Memory and terminology databases can then help maintain consistency as additional documents and language versions are produced.
This becomes particularly important when multiple linguists, reviewers, vendors, or internal teams contribute to the same submission.
3. Regional Language Differences Can Affect Regulatory Content
Language requirements are not always interchangeable across markets.
A clinical or regulatory document intended for one region may require terminology or linguistic conventions that differ from another market. The distinction can be particularly important when materials are translated into languages used across multiple countries or regulatory environments.
A translation can therefore be linguistically correct without being appropriately localized for its intended audience. Before translation begins, teams should establish the target market, intended audience, applicable terminology, and any regional requirements that could affect the content.
This is especially important for global clinical programs where the same source material may need to support multiple markets.
4. Version Control Is a Translation Issue, Too
Regulatory documentation can change throughout the submission process.
A source document may be revised after translation has started. A new file may replace an earlier version. A section may be updated while other related documents remain unchanged.
Without clear version control, a translated document can become misaligned with the source material even when the translation itself is accurate.
A controlled workflow should make it possible to determine which source version was translated, whether changes were introduced after translation, and which translated files need to be updated.
This is particularly important for large submissions where documents are delivered in multiple batches.
5. Document Quality Can Affect Translation Quality
The quality of the source material directly affects what can be done with it.
Regulatory teams may need to work with scanned PDFs, image-based documents, spreadsheets, reports, handwritten content, or files assembled from multiple sources. Some documents may require OCR or additional preparation before translation can begin.
Poor source quality can create downstream problems such as missing text, formatting issues, or uncertainty around content that cannot be reliably extracted.
A document assessment or triage process can help identify these issues before translation begins.
Files can be reviewed for completeness, readability, language, duplication, formatting, and extraction requirements. Content that requires additional clarification or review can then be identified before it enters the translation workflow.
6. Translation Timelines Can Become a Submission Bottleneck
Translation is sometimes scheduled after the rest of the submission timeline has been established.
That can create unnecessary pressure.
When large volumes of content require translation close to a submission deadline, there is less time for terminology decisions, linguistic review, formatting, source-to-target comparison, corrections, and final quality assurance.
A faster translation process does not necessarily solve the problem if there is insufficient time for the controls surrounding the translation.
Instead, translation requirements should be incorporated into submission planning early enough to account for document preparation, translation, review, updates, and final delivery.
This gives regulatory teams more flexibility when source documents change or unexpected volumes enter the workflow.
7. AI-Assisted Translation Requires Appropriate Oversight
AI-assisted translation and other language technologies are increasingly being incorporated into multilingual workflows.
For large regulatory programs, these technologies can help organizations manage volume, improve workflow efficiency, and support terminology and content management. But technology does not eliminate the need for appropriate quality controls.
The level of human review and validation should reflect the content, intended use, and risk associated with the translation.
For regulatory teams, the important question is not simply whether AI or machine translation is being used. It is whether the workflow provides appropriate controls around that technology.
That can include defined use cases, terminology controls, expert review, quality evaluation, document-level checks, and clear escalation processes for content that requires additional expertise.
Why Translation Needs to Be Part of Submission Planning
These risks have something in common: most are easier to address before submission than after a problem has been identified.
That means translation should be considered alongside other submission planning activities rather than treated as a final production task.
An effective workflow may include:
Document intake: Identify required files, languages, document types, and delivery requirements.
Source assessment: Review documents for completeness, readability, formatting, OCR requirements, and embedded content.
Terminology management: Establish and maintain approved terminology across documents, languages, and project phases.
Translation and review: Assign qualified linguists and subject matter experts according to the content and intended use.
Quality assurance: Check linguistic accuracy, terminology, formatting, completeness, and source-to-target alignment.
Change management: Track source revisions and determine whether translated content requires updating.
Final review: Confirm that translated files are complete and ready for the next stage of the submission process.
The objective is not to create unnecessary complexity. It is to create enough visibility and control to identify issues while there is still time to resolve them.
A Real-World Example of Translation Risk
The consequences of these gaps become clearer when a submission involves significant volume and limited time.
In one Morningside case study, a global pharmaceutical team faced potential FDA delays after identifying untranslated embedded content and misaligned files within a large clinical submission. The project ultimately involved approximately 1.2 million words across multiple languages.
Morningside helped the team establish a structured workflow to identify and manage the content, align stakeholders, and address the translation risks before submission.
The team was able to submit on time, avoiding the additional review cycles that the initial issues could have created.
The lesson is not simply that translation errors can delay a submission.
It is that translation risk can exist within the broader document and workflow environment—and that managing the process around translation can be just as important as the linguistic work itself.
What Should Regulatory Teams Review Before Submission?
Before a global FDA submission reaches its final stages, regulatory teams can use a simple set of questions to identify potential translation gaps:
- Are all source files complete and accounted for?
- Has embedded or non-editable content been identified?
- Are source versions controlled throughout the project?
- Is terminology consistent across languages and document types?
- Have regional language requirements been established?
- Is there sufficient time for translation, review, and revisions?
- Are AI-assisted or automated workflows subject to appropriate quality controls?
- Has the final translated content been checked for completeness and alignment with the source?
These questions can help reveal risks that may not be apparent during a standard linguistic review.
Translation Readiness Is Part of Submission Readiness
For global clinical and regulatory programs, translation sits at the intersection of language, documentation, technology, and regulatory operations.
That makes it difficult to separate translation quality from the quality of the workflow surrounding it.
A submission-ready translation should be accurate and consistent, but it should also be complete, traceable, appropriately localized, and supported by a quality process designed for regulated content.
The earlier these considerations are incorporated into submission planning, the more opportunity regulatory teams have to identify and resolve potential problems before they affect the submission timeline.
A Practical Checklist for Your Next FDA Submission
Translation risks are often easier to prevent than to correct.
To help regulatory teams identify common gaps before they become submission problems, Morningside created 7 Red Flags That Put Your FDA Submission at Risk.
The guide covers seven common areas of translation risk and provides a practical checklist for reviewing clinical and regulatory translation workflows.
Download the free guide: 7 Red Flags That Put Your FDA Submission at Risk
For complex multilingual clinical and regulatory programs, Morningside supports life sciences organizations with specialized translation, terminology management, document processing, quality assurance, and project management designed around the needs of regulated content.
Learn more about Morningside’s Life Sciences Translation Services.
Frequently Asked Questions
Q: What translation risks can affect an FDA submission?
Translation risks can include inaccurate or inconsistent terminology, untranslated embedded content, incomplete files, version-control issues, regional language differences, formatting problems, and insufficient quality review. These risks can create rework or delays if they are identified late in the submission process.
Q: Does the FDA require foreign-language documents to be translated into English?
Requirements vary depending on the type of submission and documentation involved. FDA guidance and submission requirements establish circumstances where English translations of foreign-language materials are required or expected. Regulatory teams should review the requirements applicable to their specific submission.
Q: Why is terminology management important for FDA submissions?
Regulatory submissions often use specialized clinical, technical, and safety terminology repeatedly across multiple documents. Controlled terminology helps maintain consistency, reduce ambiguity, and ensure that the same concepts are represented consistently throughout translated materials.
Q: What is embedded content in a regulatory document?
Embedded content includes information contained within figures, charts, images, screenshots, tables, annotations, headers, footnotes, or other elements that may not be captured during standard text extraction. If this content contains information that requires translation, it needs to be identified and managed as part of the translation workflow.
Q: Can AI or machine translation be used for FDA submission content?
AI-assisted and machine translation technologies can support certain regulated translation workflows, particularly when managing large volumes of content. However, their use should be supported by appropriate terminology management, quality controls, human expertise, and review processes based on the content and its intended regulatory use.
Q: How can regulatory teams reduce translation-related submission delays?
Teams can reduce risk by involving translation early in submission planning, assessing source files before translation, establishing terminology requirements, maintaining version control, allowing sufficient time for linguistic and quality review, and conducting a final completeness check before submission.
Q: What should I look for in an FDA regulatory translation provider?
Regulatory teams should consider a provider’s life sciences expertise, experience with FDA-related documentation, subject matter expertise, terminology management capabilities, quality processes, document processing capabilities, security controls, scalability, and ability to manage complex, time-sensitive workflows.
Q: How can I identify translation risks before an FDA submission?
A structured pre-submission review can help identify issues with completeness, embedded content, terminology, regional language, source versions, workflow timing, and quality control. Morningside’s 7 Red Flags That Put Your FDA Submission at Risk guide provides a practical checklist for this review.
Leslie Yale is a Business Development Representative at Morningside, with over 10 years of experience in the translation and localization industry. Fluent in both French and English, Leslie began her career as a translator before advancing into project management and leadership roles, giving her a comprehensive understanding of the language services lifecycle. Throughout her career, she has developed expertise in translation, localization, workflow management, and client services across a variety of industries. Drawing on her linguistic background and operational experience, she is committed to helping clients achieve high-quality results, streamline global communication, and successfully bring their products and content to international markets.