DossierTrans

Baddi 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 India-specific dossiers and technical documents, with dedicated service support for pharmaceutical, formulation, and API manufacturing units based in Baddi–Barotiwala–Nalagarh (BBN) industrial area.

We support manufacturers, exporters, importers, contract manufacturers, CROs, consultants, and regulatory teams in Baddi with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, approvals, and post-approval compliance across India.

Who We Are

DossierTrans is a specialized regulatory translation service provider, focused exclusively on scientific, pharmaceutical, and technical documentation for Indian regulatory submissions and export-oriented dossiers.

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 CDSCO / FSSAI / AYUSH / BIS / HP State Drug Control expectations

Regulatory Alignment – Baddi / India

Our services are fully aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO)
• Ministry of Health & Family Welfare (MoHFW)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Himachal Pradesh State Drug Control Administration
• Import & Export Regulatory Authorities of India

Our Core Services – Baddi

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Finished formulation dossiers (tablets, capsules, injectables, syrups, etc.)
• API and excipient documentation
• SmPC, PIL, labels, leaflets & artwork text (India-compliant)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS, MSDS & technical files
• Import registration, manufacturing license & MA 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 Indian Pharmacopoeia (IP), CDSCO guidelines & ICH references

🛡️ Post-Submission Regulatory Query Handling – Baddi

• CDSCO / HP State Drug Controller queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with Baddi-based manufacturers, consultants & QA/RA teams

Languages We Support (Baddi-Focused)

We provide professional, native-level regulatory translations relevant to Indian submissions and exports:

🌍 International Languages

• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean

🇮🇳 Indian Language Support

• English (Indian regulatory format)
• Hindi
• Regional languages – on request, where required

Foreign Language ↔ English | English ↔ Indian Languages

All translations are reviewed by scientific and regulatory experts familiar with Indian and HP-specific regulations.

Industries We Serve – Baddi Industrial Cluster

We provide specialized translation and review services for:

• Pharmaceutical Finished Dosage Forms
• APIs & Excipients
• Contract Manufacturing & Third-Party Manufacturing
• OTC, Cosmetics & Personal Care Products
• Herbal & AYUSH Products
• Food & Nutraceutical Ingredients

Why Choose DossierTrans in Baddi?

✅ Deep understanding of Baddi pharmaceutical manufacturing ecosystem
✅ Proven experience with CDSCO & HP State Drug Control submissions
✅ Finished formulation–focused regulatory translation expertise
✅ Native-language scientific reviewers
✅ Terminology consistency across Indian and export dossiers
✅ Authority-ready documentation
✅ End-to-end support including post-approval queries
✅ Strict confidentiality & data security

India & Global Regulatory Support from Baddi

Our Baddi services support:

• Domestic Indian regulatory submissions
• Export dossiers for US FDA, EU, Canada, GCC & ROW markets
• Import registration and compliance documentation
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence in a formulation dossier can delay manufacturing approvals, inspections, or product launches.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Baddi’s pharmaceutical manufacturing hub.

DossierTrans – Translating Science into Regulatory Approval from Baddi