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