DossierTrans

Malta 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 Malta-specific dossiers and technical documents, aligned with Maltese regulatory authorities and European Union (EU) statutory requirements.

We support manufacturers, exporters, importers, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and approvals in Malta and the wider EU system.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Maltese 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 that translated dossiers maintain:

• Scientific accuracy

• Regulatory intent

• Terminology consistency

• Compliance with Malta Medicines Authority (MMA) and EU/EMA expectations

Maltese Regulatory Alignment

Our services are aligned with the requirements of:

• Malta Medicines Authority (MMA) (The National Competent Authority for medicines)

• Superintendent of Public Health (The Licensing Authority)

• Malta Competition and Consumer Affairs Authority (MCCAA) (For Medical Devices/other product regulation)

• European Medicines Agency (EMA) procedures

• EU Directives and Regulations (e.g., MDR, IVDR, Cosmetics Regulation)

Our Core Services – Malta (EU Member State)

📘 Dossier & Technical Document Translation

• EU CTD / non-CTD dossier formats for National, MRP, and DCP submissions

• Product Information (PI): Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and Labelling/Artwork text (compliant with QRD/MMA requirements)

• Stability, validation & study reports

• SOPs, specifications, COAs, SDS & technical files

• Documentation for local Marketing Authorisation (MA) and product registration

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents

• Cross-verification with source (English/other EU language) dossiers

• Identification of terminology errors, inconsistencies & compliance gaps

• Alignment with Maltese legislative/EU templates and regulatory references

🛡️ Post-Submission Regulatory Query Handling – Malta

• Malta Medicines Authority (MMA) queries related to translated content (e.g., during DCP/MRP/National procedure)

• Scientific clarification and regulatory re-wording support

• Revised translations as per authority observations

• Coordination with applicants, consultants, and local agents/Qualified Persons

Languages We Support (Malta & EU-Focused)

We provide professional, native-level regulatory translations relevant to Maltese submissions and EU regulatory processes:

🇪🇺 Official & International Languages (for EU/Malta Submissions)🇲🇹 Local Language Support* English (Official EU Language)* Maltese (Malti) (Official EU Language)* FrenchEnglish ↔ Maltese | Maltese ↔ English* German* Other European languages (as required by EU procedures)* Spanish* Italian

All translations are reviewed by scientific and regulatory experts familiar with Maltese and EU regulations.

Industries We Serve – Malta

We provide specialized translation and review services for:

• Pharmaceuticals & APIs

• Medical Devices & IVDs

• Cosmetics & Personal Care

• Food Supplements & Nutraceuticals

• Industrial Chemicals (REACH/CLP documentation)

Why Choose DossierTrans for Malta?

✅ EU/Maltese-regulatory-focused translation

✅ Expertise in MMA and EMA documentation standards (e.g., QRD)

✅ Native-language scientific reviewers with regulatory expertise

✅ Terminology consistency across EU and local submissions

✅ Authority-ready documentation

✅ End-to-end support including post-approval queries

✅ Strict confidentiality & data security

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Maltese/EU regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Maltese and European compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Malta.