Summary
- Profile Type
- Business Offer
- POD Reference
- BORS20250515019
- Term of Validity
- 27 May 2025 - 27 May 2026
- Company's Country
- Serbia
- Type of partnership
- Outsourcing agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- With 18 years of experience and led by a certified medical doctor, this Serbian company offers specialized medical translation services for clinical trials, regulatory submissions, and medical device documentation. It provides high-quality translations between major world languages and seeks outsourcing partnerships with CROs, biotech, pharma, and medical device companies.
- Full Description
-
The Serbian company has 18 years of experience providing professional translation and localization services with a strong specialization in the medical and life sciences sectors. It serves international clients across Europe and North America, including some of the largest CROs and language service providers (LSPs). The company operates in compliance with ISO 17100, with a medical translation team led by a certified medical doctor and supported by subject-matter experts. Clients include organizations in clinical research, pharmaceutical, biotech, and medical device manufacturing.
The company provides complete linguistic support for companies developing medical devices who need to translate regulatory, technical, or user-facing content. It also supports LSPs looking to outsource part of their medical translation workflows.
Services include translation, revision, terminology management, and file preparation. Document types covered include:
• Instructions for use (IFUs)
• Regulatory submissions (CE marking, MDR/IVDR documentation)
• Clinical trial protocols and informed consent forms (ICFs)
• Patient questionnaires, PILs, and SmPCs
• Packaging and labelling
• Marketing and training materials related to medical devices and pharmaceuticals
Medical Expertise:
• Medical translation team led by a certified medical doctor with 15+ years of experience
• In-house and freelance healthcare professionals
• Focus areas: clinical trials, regulatory submissions, informed consent forms (ICFs), patient-facing content, medical device documentation
Languages covered: Western & Central Europe, Central & South-Eastern Europe and Northern Europe.
Tools & Quality Assurance:
• Use of computer assisted tools (CAT)
• Project-specific terminology databases and validated glossaries
• Mandatory revision by a second linguist and medical quality check (QC)
• Integrated QA tools and error tracking (e.g. Xbench, Verifika)
Data Security: Secure translation platforms with access control, encryption, and NDA compliance.
The company is interested in establishing outsourcing agreement with:
• Medical device manufacturers
• Pharma/biotech companies
• Large LSPs in need of reliable medical translation partners.
Under such agreement, the company delivers final deliverables including:
• Translated and revised files
• Translation memory (TMX format)
• Terminology lists (if applicable)
• QA reports (if required by the partner)
• All services are managed by dedicated project managers and linguists with medical expertise. Confidentiality is guaranteed through NDA agreements and secure platforms. - Advantages and Innovations
-
• The company has over 18 years of experience in professional translation, with a strong focus on medical and life sciences content.
• It is ISO 17100 certified and a member of key industry associations: GALA, EUATC and Elia.
• Clients & Reference:
- Long-term provider for Swiss CRO since 2007, medical device manufacturer since 2008, Hungarian CRO since 2010
- Active clients from Poland, Italy, United States, Turkey, Switzerland, Slovenia, Slovakia, Hungary, Germany, France, Denmark, Bulgaria, Austria
- Over 15 million words translated in the medical sector to date
• Medical translation team led by a certified medical doctor with 15+ years of experience
• Languages Covered:
- Western & Central Europe: English, German, French, Spanish, Italian, Portuguese, Dutch
- Central & South-Eastern Europe: Serbian, Croatian, Bosnian, Slovenian, Macedonian, Albanian, Romanian, Bulgarian, Greek, Hungarian, Polish, Czech, Slovak
- Northern Europe: Danish, Swedish, Norwegian
• Turnaround: documents up to 2,000 words delivered within 24–48 hours - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- Goal 4: Quality Education
- Goal 10: Reduced Inequality
Partner Sought
- Expected Role of a Partner
-
Type of partners: Contract research organizations (CROs), medical device manufacturers, pharmaceutical or biotechnology companies
Role: It is expected from industry partners to require high-quality medical translation services (e.g., clinical trials, regulatory documents, IFUs, product labelling). The partner is expected to:
• Ensure timely delivery of source documentation and relevant background materials to allow efficient and accurate translation workflows.
• Assign a dedicated contact person for coordination and clarification of content, terminology, or regulatory expectations.
• Provide clear expectations and timelines in advance, including regulatory deadlines and quality assurance requirements. - Type and Size of Partner
- SME <=10
- Big company
- R&D Institution
- SME 50 - 249
- SME 11-49
- Type of partnership
- Outsourcing agreement
Dissemination
- Technology keywords
- 06001015 - Pharmaceutical Products / Drugs
- 06001013 - Medical Technology / Biomedical Engineering
- 06001005 - Diagnostics, Diagnosis
- 06001002 - Clinical Research, Trials
- 06001012 - Medical Research
- Market keywords
- 02007012 - Medical/health software
- 02006004 - Data processing, analysis and input services
- 09003005 - Consulting services
- Sector Groups Involved
- Health
- Targeted countries
- All countries