DossierTrans – Malawi

Malawi 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 Malawi-specific dossiers and technical documents, aligned with Malawian regulatory authorities and statutory requirements.

We support Malawian 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 Malawi.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Malawi 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 Malawi-specific PMRA / MoH expectations

Malawi Regulatory Alignment

Our services are aligned with the requirements of:

• Pharmacy and Medicines Regulatory Authority (PMRA), Malawi
• Ministry of Health (MoH), Republic of Malawi
• Pharmacy and Medicines Act, Malawi
• PMRA Guidelines for Medicines Registration
• WHO prequalification & reliance pathways (where applicable)
• Malawi Bureau of Standards (MBS)
• Malawi Revenue Authority (MRA) – Customs & Excise
• Other applicable import & export regulatory authorities in Malawi

Our Core Services – Malawi

📘 Dossier & Technical Document Translation

• Malawi-specific CTD / non-CTD dossier formats
• Module 1–5 translations for PMRA 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 PMRA guidelines, MoH requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Malawi

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

Languages We Support (Malawi-Focused)

🌍 International Languages

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

🇲🇼 Local & Regional Language Support

• English (official regulatory language)
• Chichewa – where required for public-health or NGO documentation

English ↔ Chichewa | Foreign Language ↔ English / Chichewa

All translations are reviewed by regulatory experts experienced with PMRA Malawi requirements.

Industries We Serve – Malawi

• 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 Malawi?

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

Global & Malawi Regulatory Expertise

Our Malawi services support:

• PMRA 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 PMRA approval in Malawi.

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

DossierTrans – Translating Science into Regulatory Approval in Malawi

If you’d like next, I can:
✔ Prepare SEO-optimized Malawi landing page content
✔ Create English–Chichewa bilingual brochures
✔ Develop PMRA-only pharma / medical device / food versions
✔ Convert this for Zambia, Mozambique, Zimbabwe, SADC, Africa, or LATAM