DossierTrans – Botswana

DossierTrans – Botswana

Botswana Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Botswana-specific dossiers and technical documents, aligned with Botswana regulatory authorities and statutory requirements.

We support Botswana manufacturers, importers, exporters, marketing authorization holders, NGOs, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Botswana.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Botswana market, focused exclusively on scientific, pharmaceutical, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.

We ensure every translated dossier preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Botswana-specific MoH / BOMAID / MCA expectations

Botswana Regulatory Alignment

Our services are aligned with the requirements of:

• Botswana Medicines Regulatory Authority (BoMRA)
• Ministry of Health (MoH), Republic of Botswana
• Medicines and Related Substances Act, Botswana
• BoMRA Guidelines for Medicines Registration
• Botswana Bureau of Standards (BOBS)
• Botswana Unified Revenue Service (BURS) – Customs & Excise
• Other applicable import & export regulatory authorities in Botswana

Our Core Services – Botswana

📘 Dossier & Technical Document Translation

• Botswana-specific CTD / non-CTD dossier formats
• Module 1–5 translations for BoMRA submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (English-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import permit & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with BoMRA guidelines, MoH requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Botswana

• BoMRA / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, local agents, distributors, and consultants

Languages We Support (Botswana-Focused)

🌍 International Languages

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

🇧🇼 Local & Regional Language Support

• English (official regulatory language)
• Setswana – where required for public-facing or program-specific documentation

English ↔ Setswana | Foreign Language ↔ English / Setswana

All translations are reviewed by regulatory experts experienced with BoMRA requirements.

Industries We Serve – Botswana

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Botswana?

✅ Botswana-regulatory-focused translation (not generic translation)
✅ Proven expertise in BoMRA documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Botswana submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Botswana Regulatory Expertise

Our Botswana services support:

• BoMRA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for SADC, Southern Africa & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a BoMRA approval in Botswana.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Botswana compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Botswana

If you’d like next, I can:
✔ Prepare SEO-optimized Botswana landing page content
✔ Create English–Setswana bilingual brochures
✔ Develop BoMRA-only pharma / medical device / food versions
✔ Convert this for Namibia, Zambia, Zimbabwe, South Africa, GCC, or LATAM