Language isn't just a formality when ensuring multilingual regulatory compliance, especially for FDA submissions. It's a compliance variable. A risk factor. A potential blocker to market entry.
MedTech and Life Sciences companies with clinical trials in Switzerland or the EU often deal with complex document sets: handwritten notes, redacted files, scanned PDFs, and content authored in multiple languages, such as Swiss German or Swiss French. These aren't niche complications. They are widespread risks that can delay submissions, trigger agency queries, or even result in rejection.
That's what one global orthopedic device manufacturer faced. After a successful European launch, they were scaling toward U.S. commercialization—until a sudden FDA safety alert forced them into a time-critical supplemental submission. The content? Nearly a million words of Swiss German and Swiss French clinical data were redacted, handwritten, and challenging to process.
Why Multiple Official or Regional Languages Raise the Stakes for Multilingual Regulatory Compliance
Countries with multiple official or regional languages introduce unique challenges for multilingual regulatory compliance. Even when a dominant language exists, documents may include content in secondary languages—often embedded within notes, reports, or redacted sections. These segments can be overlooked during initial scoping, leaving critical information untranslated and potentially causing incomplete regulatory submissions, agency questions, or delays. Automated language detection is often unreliable without human review, and many companies assume their files are monolingual until it's too late.
In Morningside's high-stakes FDA rescue, our client was based in Switzerland, a linguistically unique country. While German is most widely spoken, Swiss German differs significantly from High German in vocabulary, spelling, and structure. It's rarely written formally and is heavily contextual, making it unsuitable for automated translation or generalist linguists.
While more standardized, Swiss French often appears embedded within Swiss German documents, particularly in bilingual regions or investigator notes. Our team discovered multiple unflagged French-language segments not scoped in the initial file inventory. If these had gone untranslated, the FDA submission would have been incomplete.
The Hidden Challenge of Redacted PDFs and Handwritten Notes
Even more problematic than language can be format, and not every language provider can handle the challenge. That is where Morningside aims to make a difference.
Nearly every file came in as a scanned, redacted PDF, with no editable source. Many had annotations, strikethroughs, or handwritten investigator comments. Some were nearly illegible. Others alternated between typed Swiss German and cursive French on the same page.
These aren't translation-ready formats. Before any linguistic work could begin, Morningside's team had to manually reconstruct hundreds of documents, converting static scans into clean, editable Word files while preserving:
- Original formatting and layout
- Confidential redactions
- Terminology integrity
- Annotations and page logic
This step is often overlooked, but it's critical. If formatting is off or the submission includes broken tables, cut-off text, or misaligned annotations, your documents can be rejected before content is reviewed.
Real Pitfalls in Multilingual Regulatory Compliance Submissions
Here's what most companies underestimate when managing clinical translation from multilingual trial regions like Switzerland:
1. Embedded Languages Go Undetected
Your submission could have untranslated content if you don't flag bilingual sections early. The risk isn't just missing words; it's in failing to disclose critical trial outcomes or safety data.
2. File Inventories Don't Match Deliverables
Especially with redacted content, what you think you're submitting and what's delivered often differs. Without a dynamic, phase-aligned file tracking system, critical files may be skipped, or the wrong ones processed.
3. Terminology Drifts Across Batches
Without a centralized terminology system, medical concepts can be translated inconsistently. In regulatory contexts, inconsistency signals risk. It creates doubt about quality control—and in the FDA's eyes, that can mean more questions or extended review timelines.
4. OCR Tools Fail on Complex Files
Optical character recognition (OCR) struggles with handwritten or heavily redacted content. Poor OCR extraction leads to incomplete translations, spelling errors, and layout issues that don't pass submission standards.
How Morningside Solves It
This was a high-stakes regulatory rescue. Over nearly two years, Morningside managed 13 overlapping translation phases, each under deadline pressure and evolving scope.
Here's how we responded:
- Language audits on every file batch to uncover any Swiss French segments missed in scoping
- Manual reconstruction of every redacted PDF into FDA-ready formats, using trained specialists—not just OCR
- Certified medical linguists fluent in both Swiss German and Swiss French, supported by QA reviewers with regulatory submission experience
- Custom file-tracking and triage systems, synced to FDA submission checkpoints so the most urgent documents were prioritized
- Rolling delivery model, so translated files were delivered in sequence, allowing regulatory teams to review and respond continuously rather than waiting on full batch delivery
When a particularly complex batch arrived, with pages of handwritten notes, new French content, and an urgent turnaround needed, our team didn't flinch and worked overnight to rebuild, translate, and deliver the documents before the next morning's checkpoint.
As the client later said:
"Morningside didn't just meet deadlines;
they anticipated problems before we even saw them. Their proactive
communication turned a high-stress situation into a manageable
process. It felt like an entire in-house team was dedicated to our
submission."
— Regulatory Affairs Lead, Global Medical Device
Manufacturer
Why Multilingual Regulatory Compliance Matters Now More Than Ever
The reality is that multilingual regulatory compliance isn't optional anymore. Clinical trials are becoming more global, and regulators are demanding more transparency, formatting consistency, and traceability of translated content.
If your data is stored across languages and documents, especially in scanned or redacted formats, you need a partner that goes beyond surface-level translation.
You need:
- Language detection and triage at intake
- Medical-trained linguists familiar with EU trial structure
- A formatting and QA team to reconstruct and certify every file
- Project managers who communicate constantly, align with submission phases, and adapt on the fly
That's how you prevent errors. That's how you preserve trust with the FDA. And that's how you protect your path to market.
Want to see how this played out? Read our case study!
Watch our 2-minute FDA rescue video
Discover how Morningside helped preserve U.S. market access for a
next-gen medical device—despite language mismatches, redacted
content, and tight regulatory deadlines.
To watch video, please click here.
TL;DR
When submitting multilingual regulatory documents—especially to the FDA—language and format aren't just details; they're compliance risks. MedTech companies running clinical trials in regions like Switzerland face Swiss German and Swiss French content in handwritten, redacted, or scanned PDFs. These formats and embedded languages can delay submissions, trigger queries, or cause outright rejection.
Morningside helped a global orthopedic device company navigate nearly a million words of complex content by:
- Auditing files for embedded languages
- Reconstructing redacted PDFs into editable, submission-ready formats
- Using certified linguists fluent in Swiss German and Swiss French
- Maintaining centralized terminology and dynamic file-tracking aligned to submission phases
- Delivering rolling batches to enable continuous regulatory review
The result: the FDA submission met deadlines, avoided errors, and preserved U.S. market access.
Key takeaway: Multilingual regulatory compliance is now critical. Without specialized linguists, robust QA, and proactive project management, translation errors and formatting issues can derail high-stakes submissions.
Originally published Aug 14, 2025
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
