DossierTrans
United States Dossier & Technical Document Translation Services
Accurate. FDA-Compliant. Authority-Ready.
DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for United States–specific dossiers and technical documents, fully aligned with US FDA regulations, federal statutes, and authority expectations.
We support US manufacturers, importers, exporters, ANDAs/NDA applicants, regulatory consultants, CROs, and global companies targeting the US market with precise, technically accurate, and FDA-acceptable translations, ensuring smooth submissions, inspections, approvals, and post-approval compliance in the United States.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the United States market, focused exclusively on scientific, pharmaceutical, medical, and technical documentation.
All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.
We ensure that translated dossiers consistently maintain:
• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with US FDA / CFR / FDA Guidance expectations
United States Regulatory Alignment
Our services are fully aligned with the requirements of:
• US Food and Drug Administration (US FDA)
• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Office of Regulatory Affairs (ORA)
• United States Code of Federal Regulations (21 CFR)
• US Customs & Border Protection (CBP)
• Environmental Protection Agency (EPA) – where applicable
Our Core Services – United States
📘 Dossier & Technical Document Translation
• US-specific CTD / eCTD / non-eCTD dossier formats
• Module 1–5 translations for IND, NDA, ANDA, BLA & DMF submissions
• US FDA-compliant labeling: Prescribing Information (PI), Patient Information, Medication Guides
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Drug Master Files (Type II–V) documentation
• Import, export & facility registration documentation
🔍 Review of Translated Dossiers
• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with USP–NF, FDA Guidance documents, ICH & CFR references
🛡️ Post-Submission Regulatory Query Handling – United States
• US FDA deficiency letters, IRs & CRLs related to translated content
• Scientific clarification and FDA-style regulatory re-wording support
• Revised translations addressing FDA observations
• Coordination with US agents, regulatory consultants, CROs & applicants
Languages We Support (US-Focused)
We provide professional, native-level regulatory translations relevant to US submissions and imports:
🌍 International Languages (for US FDA Submissions)
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean
🇺🇸 US Language Support
• English (US FDA regulatory format)
• Spanish (FDA labeling & patient-facing documentation)
Foreign Language ↔ US English
All translations are reviewed by scientific and regulatory experts experienced with US FDA submissions.
Industries We Serve – United States
We provide specialized translation and review services for:
• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Medical Devices & Combination Products
• Cosmetics & OTC Products
• Dietary Supplements & Nutraceuticals
• Chemicals & Specialty Materials
• Agrochemicals & Environmental Products
Why Choose DossierTrans for the United States?
✅ US FDA–focused translation (not generic translation)
✅ Expertise in IND, NDA, ANDA, DMF & eCTD documentation
✅ Native-language scientific & regulatory reviewers
✅ Consistent FDA-compliant terminology
✅ Authority-ready documentation
✅ End-to-end support including FDA queries & post-approval changes
✅ Strict confidentiality, data integrity & compliance
Global & United States Regulatory Expertise
Our US services support:
• US FDA submissions & registrations
• Manufacturing facility documentation & inspections
• Import alerts & compliance remediation
• Export-support translations for global markets
• Post-approval supplements, variations & renewals
Our Commitment
At DossierTrans, we understand that a single mistranslated sentence can delay, refuse, or place a US FDA submission on hold.
That’s why we deliver precision-driven, FDA-acceptable translations aligned with US regulatory and compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in the United States
If you want, I can next:
✔ Create US FDA–specific service landing pages (Pharma / Devices / Supplements)
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✔ Convert it into an FDA-ready brochure or capability statement
Canada
Below is the fully converted and localized version of your content for Canada, precisely aligned with Health Canada and federal regulatory requirements, while retaining your original structure, tone, and regulatory positioning.
DossierTrans
Canada Dossier & Technical Document Translation Services
Accurate. Health Canada–Compliant. Authority-Ready.
DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Canada-specific dossiers and technical documents, fully aligned with Health Canada regulations, federal statutes, and authority expectations.
We support Canadian manufacturers, importers, exporters, Marketing Authorization Holders (MAHs), regulatory consultants, CROs, and global companies targeting the Canadian market with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, approvals, and post-approval compliance in Canada.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Canadian market, focused exclusively on scientific, pharmaceutical, medical, and technical documentation.
All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.
We ensure that translated dossiers consistently maintain:
• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Health Canada / Food and Drugs Act / Guidance Document expectations
Canada Regulatory Alignment
Our services are fully aligned with the requirements of:
• Health Canada
• Health Products and Food Branch (HPFB)
• Therapeutic Products Directorate (TPD)
• Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
• Medical Devices Directorate (MDD)
• Natural and Non-prescription Health Products Directorate (NNHPD)
• Food Directorate (CFIA / Health Canada)
• Canadian Food Inspection Agency (CFIA)
• Canada Border Services Agency (CBSA)
Our Core Services – Canada
📘 Dossier & Technical Document Translation
• Canada-specific CTD / eCTD / non-eCTD dossier formats
• Module 1–5 translations for NDS, ANDS, SNDS, DIN & DMF submissions
• Bilingual labeling (English–French) compliant with Health Canada
• Product Monographs (PM), PILs, IFUs & artwork text
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import, establishment licensing & site registration documentation
🔍 Review of Translated Dossiers
• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with USP, BP, EP, Ph.Eur., ICH & Health Canada guidance
🛡️ Post-Submission Regulatory Query Handling – Canada
• Health Canada deficiency letters, screening questions & clarification requests related to translated content
• Scientific clarification and Health Canada-style regulatory re-wording support
• Revised translations addressing authority observations
• Coordination with Canadian MAHs, consultants, CROs & local agents
Languages We Support (Canada-Focused)
We provide professional, native-level regulatory translations relevant to Canadian submissions and imports:
🌍 International Languages
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean
🇨🇦 Official & Regulatory Languages
• English (Health Canada regulatory format)
• French (mandatory bilingual compliance)
Foreign Language ↔ English / French | English ↔ French
All translations are reviewed by scientific and regulatory experts experienced with Canadian regulations.
Industries We Serve – Canada
We provide specialized translation and review services for:
• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Medical Devices & Combination Products
• Natural Health Products (NHPs)
• OTC & Cosmetics
• Food, Nutraceuticals & Dietary Supplements
• Chemicals & Specialty Materials
Why Choose DossierTrans for Canada?
✅ Health Canada–focused translation (not generic translation)
✅ Expertise in NDS, ANDS, DIN, DMF & bilingual compliance
✅ Native English & French scientific reviewers
✅ Consistent Health Canada–compliant terminology
✅ Authority-ready bilingual documentation
✅ End-to-end support including post-approval queries & variations
✅ Strict confidentiality, data integrity & compliance
Global & Canada Regulatory Expertise
Our Canada services support:
• Health Canada submissions & registrations
• Establishment licensing & inspections
• Import/export compliance & labeling reviews
• Export-support translations for global markets
• Post-approval changes, renewals & lifecycle management
Our Commitment
At DossierTrans, we understand that a single mistranslated sentence—especially in bilingual submissions—can delay or reject a Health Canada approval.
That’s why we deliver precision-driven, regulator-acceptable translations aligned with Canadian compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Canada