Global Dossier & Technical Document Translation Services – Globally

DossierTrans

Global Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for dossiers and technical documents across regulated global markets.

We support manufacturers, exporters, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions and faster approvals worldwide.

Who We Are

DossierTrans is a specialized regulatory translation service provider focused exclusively on scientific, pharmaceutical, and technical documentation. Our work is performed by subject-matter experts, regulatory professionals, and technical reviewers, not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy

• Regulatory intent

• Terminology consistency

• Compliance with country-specific MOH / FDA expectations

Our Core Services

📘 Dossier & Technical Document Translation

• CTD, eCTD, ACTD & country-specific dossier formats

• Module 1–5 translations

• SmPC, PIL, labels, leaflets & artwork text

• Stability, validation & study reports

• SOPs, specifications, COAs, SDS & technical files

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents

• Cross-verification with source (English) dossiers

• Identification of terminology errors, inconsistencies & regulatory risks

• Alignment with authority-approved reference documents

🛡️ Post-Submission Regulatory Query Handling

• MOH / FDA queries related to translated content

• Scientific clarification and re-wording support

• Revised translations as per authority feedback

• Coordination with applicants and local agents

Languages We Support

We provide professional, native-level regulatory translations in the following languages:

🌍 European Languages

• French

• German

• Spanish

• Italian

• Portuguese

• Dutch

• Polish

• Romanian

• Hungarian

• Czech

• Slovak

• Greek

🌏 Asian Languages

• Chinese (Simplified & Traditional)

• Japanese

• Korean

• Thai

• Vietnamese

• Indonesian

• Malay

• Filipino (Tagalog)

🌐 Middle East & Africa

• Arabic

• Turkish

• Persian (Farsi)

• Hebrew

🌎 CIS & Eurasian Languages

• Russian

• Ukrainian

• Kazakh

• Uzbek

🌍 Latin American Markets

• Spanish (LATAM)

• Brazilian Portuguese

English ↔ Local Language | Local Language ↔ English

All translations are reviewed by scientific and regulatory experts.

Industries We Serve

We provide specialized translation and review services for:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

Why Choose DossierTrans?

✅ Regulatory-focused translation (not generic language translation)
✅ Native-language scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready documentation
✅ End-to-end support including post-approval queries
✅ Confidentiality & data security assured

Global Regulatory Expertise

Our translation and review services support submissions to:

• FDA, EMA, MHRA

• ASEAN MOHs

• GCC Authorities

• LATAM Health Authorities

• CIS & African Regulatory Agencies

• ROW markets

Our Commitment

At DossierTrans, we understand that one mistranslated sentence can delay approval.
That’s why we deliver precision-driven, regulator-acceptable translations—every time.

“Because Every Word Matters in Regulatory Submissions.”

Excellence in Regulatory Translation Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Global Dossier & Technical Document Translation Services

1. What types of dossiers do you translate?

We translate CTD, eCTD, ACTD, and country-specific dossier formats, including Modules 1–5. Our services cover drug products, APIs, cosmetics, herbal, nutraceutical, agrochemical, and industrial chemical dossiers.

2. Do you provide regulatory-compliant translations or only language translation?

We provide regulatory-compliant scientific translations, not generic language translation. All documents are translated and reviewed by subject-matter experts to ensure technical accuracy and regulatory acceptability.

3. Which regulatory authorities do you support?

We support submissions to FDA, EMA, MHRA, ASEAN MOHs, GCC Authorities, LATAM Health Authorities, CIS, African, and ROW regulatory agencies.

4. Which documents can be translated?

We translate and review:

• SmPC, PIL, labels & artwork text

• Stability, validation & study reports

• Specifications, COAs & analytical methods

• SOPs, SDS & technical manuals

• Regulatory correspondence & responses

5. Do you review translated dossiers prepared by other agencies?

Yes. We offer independent technical and scientific review of translated dossiers prepared by third-party translators to identify errors, inconsistencies, and regulatory risks before submission.

6. How do you ensure translation accuracy?

Accuracy is ensured through:

• Domain-specific translators

• Native-language scientific reviewers

• Terminology harmonization with reference dossiers

• Cross-checking against regulatory guidelines and approved products

7. Can you handle MOH / FDA queries related to translation after submission?

Yes. We provide post-submission regulatory query handling, including clarification, re-translation, re-wording, and alignment with authority comments until resolution.

8. Which languages do you support?

We support major European, Asian, Middle Eastern, CIS, African, and LATAM languages, including French, German, Spanish, Portuguese, Russian, Arabic, Chinese, Japanese, Korean, and many others. Language support can be customized as per market requirements.

9. Do you provide English ↔ Local language translations?

Yes. We provide English to Local Language and Local Language to English translations, including back-translation when required by regulatory authorities.

10. How do you maintain confidentiality?

All projects are handled under strict confidentiality agreements. Data security protocols are followed, and documents are accessed only by authorized regulatory and translation experts.

11. What industries do you serve?

We serve:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Food & Nutraceutical Ingredients

• Essential Oils & Fragrances

• Agrochemicals

• Industrial Chemicals

12. What is the typical turnaround time?

Turnaround time depends on document volume, complexity, and language. Standard dossiers are delivered within agreed regulatory timelines without compromising quality or compliance.

13. Do you support urgent or fast-track projects?

Yes. Priority and fast-track translation services are available for urgent submissions, authority queries, and regulatory deadlines.

14. How do you price your translation services?

Pricing is based on:

• Document type and volume

• Target language(s)

• Technical complexity

• Review and query-handling requirements

Customized quotations are provided for each project.

15. Why should we choose your services?

Because we combine scientific expertise, regulatory knowledge, and linguistic precision—ensuring translations that regulators can understand, accept, and approve.