Tomedes Brings an Israeli Biotech's Clinical Research Documentation to English for Global Regulatory Submission

An Israeli biotech company had the science. What it needed was clinical documentation that international regulators could read, evaluate, and act on.

About the Client

An Israeli biotech company developing a novel therapeutic compound had completed a significant phase of its clinical research program and was preparing to engage with international regulatory authorities (including the FDA in the United States and the EMA in Europe) as part of its path toward global market authorization.

Israel's biotech sector is one of the most productive in the world relative to its size, generating a consistent pipeline of early and mid-stage clinical programs that require regulatory engagement with agencies whose working language is English. For an Israeli company at this stage, the quality of English-language clinical documentation is not a secondary concern. It is what determines whether regulators can evaluate the science at all.

The company needed a translation partner who understood both the Hebrew-language source materials and the English-language conventions of international pharmaceutical regulatory submissions, and who could deliver documentation that read as if it had been written by a native English-speaking regulatory affairs team.

Industry and Services

• Pharmaceutical / Life Sciences
• Clinical Research Documentation Translation
• Hebrew to English

The Challenge

Translating clinical research documentation from Hebrew into English for regulatory submission is a category of work that sits at the intersection of scientific precision, regulatory convention, and linguistic authority. The documents that support a regulatory submission are not just translations, they become part of the evidentiary record that regulators use to make authorization decisions. Three challenges defined this engagement.

1. Regulatory English that meets FDA and EMA submission standards

FDA and EMA submissions have established conventions for how clinical data is described, how safety signals are characterized, how statistical results are presented, and how the narrative sections of a clinical study report are structured. These conventions are documented in ICH guidelines (particularly ICH E3, which governs the structure and content of clinical study reports) and international regulatory reviewers are trained to read submissions that follow them. A clinical document translated from Hebrew that is linguistically accurate but does not conform to the register, structure, and terminology conventions of English-language regulatory submissions creates friction for reviewers and signals that the applicant's regulatory affairs capability may not match the quality of the underlying science.

2. Hebrew scientific and medical terminology requiring precise English rendering

Hebrew pharmaceutical and clinical research terminology has developed alongside Israel's biotech sector and does not always map directly onto established English regulatory vocabulary. Terms used in Israeli clinical practice, laboratory protocols, and research documentation sometimes have multiple possible English equivalents — and in a regulatory context, the choice between those equivalents is not a matter of preference. The correct English term is the one that appears in the relevant ICH guideline, the FDA reviewer guidance, or the EMA assessment framework for the therapeutic area in question. A translator without direct familiarity with the English-language regulatory vocabulary for the specific therapeutic area cannot make that determination reliably.

3. Consistency across a multi-document submission package

A clinical regulatory submission is not a single document. It comprises a clinical study report, a summary of clinical safety, a summary of clinical efficacy, investigator brochure updates, protocol amendments, and supporting appendices — all of which reference each other, share terminology, and must present a consistent picture of the clinical program across every section. A terminology inconsistency between the clinical study report and the safety summary (even one that is scientifically defensible) creates a discrepancy that regulatory reviewers will flag, requiring the applicant to respond and potentially delaying the assessment timeline.

Why Tomedes?

The company selected Tomedes for its ability to source translators with direct experience in Hebrew to English pharmaceutical regulatory translation and its capacity to manage a multi-document submission package as a coordinated program rather than a series of independent translation orders.

Israel's biotech sector generates consistent demand for this specific combination (Hebrew source language, English regulatory target, pharmaceutical subject matter) and Tomedes had built a specialist linguist network capable of meeting it. A dedicated project manager with experience coordinating pharmaceutical regulatory translation programs structured the engagement around the submission timeline and ensured that all documents were translated against a shared terminology reference from the first page to the last.

The Solution

1. A pre-translation regulatory terminology alignment against ICH and FDA/EMA reference documents

Before translation began, Tomedes conducted a terminology alignment exercise using the relevant ICH guidelines, FDA reviewer guidance documents, and EMA assessment reports for the therapeutic area as primary references — establishing the approved English equivalents for the key scientific, clinical, and regulatory terms that appeared throughout the submission package. Where Hebrew source terms had multiple possible English renderings, the alignment process identified the term that appeared in the applicable regulatory reference document and applied it as the mandatory equivalent throughout the program. The resulting bilingual glossary was reviewed and approved by the company's regulatory affairs lead before translation started.

2. A specialist translator with Hebrew pharmaceutical regulatory experience

The translation was handled by a linguist with a background in Hebrew to English pharmaceutical regulatory documentation and direct familiarity with ICH E3 clinical study report conventions, FDA submission standards, and EMA regulatory English. The translator applied the approved terminology reference throughout, rendered the clinical narrative sections in the register and structure that international regulatory reviewers expect, and flagged any Hebrew source passages where the scientific meaning was ambiguous — allowing the company's medical writing team to clarify intent before the English rendering was finalized rather than after submission.

3. A regulatory English review focused on submission readiness

Following the main translation pass, a second reviewer with pharmaceutical regulatory affairs experience conducted a submission readiness review — checking that the English-language documents conformed to ICH E3 structural conventions, that safety and efficacy narrative sections used the established regulatory vocabulary for the therapeutic area, and that the overall register of the translated documents matched what FDA and EMA reviewers expect to encounter in a professional submission. The review produced targeted revisions focused on regulatory language alignment rather than general linguistic editing.

4. Cross-document consistency review across the full submission package

All documents in the submission package were reviewed side by side to confirm that shared terminology, clinical definitions, safety characterizations, and efficacy descriptions were presented consistently across every section. Where the same clinical concept appeared in multiple documents, the review confirmed that a single approved English rendering was used throughout — eliminating the terminology inconsistencies that regulatory reviewers flag and that require formal written responses from the applicant.

5. Ongoing support for regulatory correspondence and agency responses

Following delivery of the main submission package, Tomedes provided ongoing translation support for the regulatory correspondence that follows initial submission — responses to agency questions, protocol amendment translations, and updated investigator brochure sections as the clinical program continued. Each new document was translated against the established terminology reference, ensuring that the language used in regulatory correspondence was consistent with the submission documents that preceded it.

The Result

When the company's regulatory affairs team submitted the clinical documentation package to the relevant international authorities, the English-language documents read as they needed to — not as translations of Hebrew source materials, but as regulatory submissions written to the standard that FDA and EMA reviewers work from every day.

The submission advanced through the initial regulatory review process without language-related queries from either agency. The company's regulatory affairs lead confirmed that the English documentation had been accepted as submission-ready without requests for linguistic clarification or reformatting.

To illustrate what that precision looks like in the source material, here is a representative passage from the clinical summary as it appears in the original Hebrew:

"התוצאות מצביעות על כך שהתרופה הפחיתה באופן משמעותי את רמות הדלקת בקבוצת הטיפול בהשוואה לקבוצת הביקורת, עם הבדל סטטיסטי מובהק."

The English rendering ("Results demonstrated a statistically significant reduction in inflammatory markers in the treatment group compared to the control group") uses the exact phrasing that appears in ICH E3 efficacy narrative conventions, not a word-for-word translation of the Hebrew. That distinction is what makes the document readable to a regulatory reviewer rather than merely accurate as a translation.

For a biotech company whose entire regulatory timeline depends on the quality of its submission documentation, that distinction is the difference between an assessment that moves forward and one that stalls.

Are you an Israeli or international biotech, pharmaceutical, or medical device company preparing clinical documentation, regulatory submissions, or agency correspondence in English for FDA, EMA, or other international authorities? Contact Tomedes today for a free consultation.