DossierTrans

Switzerland Dossier & Technical Document Translation Services

Accurate. Swissmedic-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Switzerland-specific dossiers and technical documents, fully compliant with Swissmedic regulations and Swiss legal frameworks.

We support Swiss pharmaceutical manufacturers, Marketing Authorisation Holders (MAHs), importers, distributors, CROs, regulatory consultants, and global companies targeting the Swiss market with precise, technically accurate, and Swissmedic-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in Switzerland.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Swiss market, focused exclusively on scientific, pharmaceutical, biotechnology, medical device, food, and technical documentation.

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

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Swissmedic / Therapeutic Products Act (TPA) / national guidance

Switzerland Regulatory Alignment

Our services are fully aligned with the requirements of:

• Swiss Agency for Therapeutic Products (Swissmedic)
• Federal Office of Public Health (FOPH)
• Therapeutic Products Act (TPA / HMG)
• Ordinances on Medicinal Products (OMed, OMPC)
• Swiss Clinical Trials Ordinance (ClinO)
• Swiss Customs & Market Surveillance Authorities

(Note: Switzerland is not an EU member; EU CTD principles apply with Swiss-specific adaptations.)

Our Core Services – Switzerland

📘 Dossier & Technical Document Translation

• Switzerland-specific CTD / non-CTD dossier formats
• Module 1–5 translations for national Swissmedic procedures
• SmPC (Fachinformation), PIL (Patienteninformation), labeling & artwork text
• Multilingual labeling & PILs – German, French, Italian (mandatory as applicable)
• Clinical trial documentation (protocols, IBs, ICFs)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import, manufacturing authorization & GDP/GMP documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & Swiss compliance gaps
• Alignment with Swissmedic guidance, ICH, Ph. Eur. & WHO references

🛡️ Post-Submission Regulatory Query Handling – Switzerland

• Swissmedic deficiency letters & clarification requests related to translated content
• Scientific clarification and Swiss-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local MAHs, Swiss regulatory consultants & CROs

Languages We Support (Switzerland-Focused)

We provide professional, native-level regulatory translations relevant to Swiss submissions:

🇨🇭 Mandatory & Regional Languages

• German
• French
• Italian

🌍 International Languages

• English
• Spanish
• Portuguese
• Russian

Foreign Language ↔ German / French / Italian | Foreign Language ↔ English

All translations are reviewed by native Swiss scientific and regulatory experts experienced with Swissmedic submissions.

Industries We Serve – Switzerland

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics, Vaccines & Biosimilars
• Biotechnology & Advanced Therapies
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for Switzerland?

✅ Swissmedic-focused regulatory translation (not generic EU translation)
✅ Expertise in Swiss national procedures & multilingual labeling
✅ Native German–French–Italian scientific & regulatory reviewers
✅ Consistent terminology aligned with Swiss law & Swissmedic guidance
✅ Authority-ready multilingual documentation
✅ End-to-end support including post-approval queries & variations
✅ Strict confidentiality & data security

Global & Switzerland Regulatory Expertise

Our Switzerland services support:

• Swissmedic marketing authorizations & variations
• Clinical trial submissions under Swiss ClinO
• Import & manufacturing authorization dossiers
• Export-support translations for EU, UK, US & ROW markets
• Post-approval lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence—especially across Switzerland’s multilingual labeling requirements—can delay or block a Swissmedic approval.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with Swiss regulatory and linguistic expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Switzerland