DossierTrans
Israel Dossier & Technical Document Translation Services
Accurate. MOH-Compliant. Authority-Ready.
DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Israel-specific dossiers and technical documents, fully aligned with Israeli Ministry of Health (MOH) requirements and national regulatory frameworks.
We support Israeli pharmaceutical manufacturers, importers, MAHs, distributors, CROs, regulatory consultants, and global companies targeting the Israeli market with precise, technically accurate, and MOH-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in Israel.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Israeli market, focused exclusively on scientific, pharmaceutical, biotechnology, medical device, food, and technical documentation.
All translations are performed and reviewed by subject-matter experts, regulatory professionals, and native-language technical reviewers—not general translators.
We ensure that translated dossiers consistently maintain:
• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Israeli MOH / AMAR / national guideline expectations
Israel Regulatory Alignment
Our services are fully aligned with the requirements of:
• Israeli Ministry of Health (MOH)
• Pharmaceutical Administration (AMAR)
• Medical Devices Division (AMAR – Devices)
• National Institute for Biological Standards and Control (as applicable)
• Standards Institution of Israel (SII)
• Israeli Customs & Port Health Authorities
Our Core Services – Israel
📘 Dossier & Technical Document Translation
• Israel-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for drug, biologic & generic registrations
• Hebrew-language SmPC, PIL, IFU, labels & packaging text (mandatory)
• Medical device technical documentation
• Clinical trial documentation (protocols, IBs, ICFs)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import registration & marketing authorization documentation
🔍 Review of Translated Dossiers
• Technical and scientific review of Hebrew translations
• Cross-verification with source (English or original language) dossiers
• Identification of terminology errors, mistranslations & compliance gaps
• Alignment with Israeli MOH guidance, ICH & WHO-adopted standards
🛡️ Post-Submission Regulatory Query Handling – Israel
• MOH / AMAR deficiency letters & clarification requests related to translated content
• Scientific clarification and Israel-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local MAHs, Israeli agents, CROs & regulatory consultants
Languages We Support (Israel-Focused)
We provide professional, native-level regulatory translations relevant to Israeli submissions:
🌍 International Languages
• English ↔ Hebrew (mandatory)
• English ↔ Arabic (as applicable for labeling)
• English ↔ Russian (supporting documentation)
Foreign Language ↔ Hebrew | Foreign Language ↔ English
All translations are reviewed by native Hebrew scientific and regulatory experts experienced with Israeli MOH submissions.
Industries We Serve – Israel
We provide specialized translation and review services for:
• Pharmaceuticals & APIs
• Biologics, Vaccines & Biosimilars
• Biotechnology & Advanced Therapies
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials
Why Choose DossierTrans for Israel?
✅ Israel-regulatory-focused translation (not generic translation)
✅ Expertise in Israeli MOH / AMAR documentation
✅ Native Hebrew scientific & regulatory reviewers
✅ Consistent terminology aligned with MOH expectations
✅ Authority-ready documentation
✅ End-to-end support including post-submission queries
✅ Strict confidentiality & data security
Global & Israel Regulatory Expertise
Our Israel services support:
• MOH registrations & variations
• Import & marketing authorization dossiers
• Export-support translations for US, EU & ROW markets
• Post-approval changes, renewals & lifecycle management
Our Commitment
At DossierTrans, we understand that a single incorrect Hebrew regulatory term or phrase can delay or block an Israeli approval.
That’s why we deliver precision-driven, regulator-acceptable translations, aligned with Israel’s strict regulatory and linguistic expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Israel