Life Sciences Translation Services
Advancing Global Healthcare
In the life sciences, precision saves lives. Tarjim provides expert translation services for pharmaceutical companies, medical device manufacturers, biotechnology firms, and healthcare organizations, ensuring regulatory compliance and patient safety across all markets.
Critical Role of Life Sciences Translation
The life sciences industry operates under the strictest global regulatory frameworks. Inaccurate translations can delay drug approvals, compromise patient safety, or result in regulatory non-compliance. Our specialized translators understand that excellence in life sciences translation is literally a matter of life and death.
Pharmaceutical Translation Services
Drug Development Documentation
- Clinical trial protocols and amendments
- Investigator brochures and case report forms
- Informed consent forms and patient information
- Clinical study reports and statistical analyses
- Pharmacovigilance and safety reports
Regulatory Submissions
- New Drug Applications (NDA) and MAA
- Common Technical Documents (CTD)
- FDA, EMA, and local regulatory filings
- Orphan drug designations
- Post-market surveillance reports
Commercial Documentation
- Product labeling and package inserts
- Summary of Product Characteristics (SmPC)
- Patient information leaflets
- Marketing materials and educational content
- Sales training and medical communications
Medical Device Translation
Technical Documentation
- Device specifications and user manuals
- Installation and maintenance guides
- Software documentation and interfaces
- Risk management and clinical evaluation
reports
- Quality management system
documentation
Regulatory Compliance
- CE marking technical files - FDA 510(k) and PMA submissions - ISO 13485 quality system documentation - Medical device classification documents - Post-market surveillance and vigilance reports
User-Facing Materials
- Patient instructions and safety warnings
- Healthcare professional training materials
- Mobile health app interfaces
- Wearable device instructions
- Telemedicine platform documentation
Biotechnology & Research
Research Documentation
- Scientific publications and journal articles
- Grant applications and research proposals
- Patent applications and IP documentation
- Conference presentations and abstracts
- Collaborative research agreements
Biotech Manufacturing
Good Manufacturing Practice (GMP) procedures
Standard Operating Procedures (SOPs)
Batch records and quality control documentation
Equipment validation and qualification protocols
Environmental monitoring procedures
Healthcare & Clinical Services
Clinical Documentation
- Hospital policies and procedures
- Medical records and patient charts
- Diagnostic reports and test results
- Treatment protocols and care pathways
- Quality improvement initiatives
Public Health Materials
- Health education and awareness campaigns
- Vaccination information and schedules
- Disease prevention guidelines
- Emergency response protocols
- Community health assessments
Global Legal Network
US FDA Requirements
- Good Clinical Practice (GCP) guidelines
- CFR Title 21 compliance
- Drug Safety and Risk Evaluation
- Biologics License Applications (BLA)
- Medical device classification systems
European Medicines Agency (EMA)
- European pharmacovigilance legislation
- Clinical Trials Regulation (CTR)
- Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
- Pediatric investigation plans
Gulf Cooperation Council (GCC)
- Saudi FDA (SFDA) requirements
- UAE Ministry of Health guidelines
- Kuwait Drug and Food Control
- Regional harmonization initiatives
- Traditional medicine regulations
Specialized Translation Areas
Oncology & Rare Diseases
- Immunotherapy documentation
- Rare disease research
- Compassionate use programs
- Patient advocacy materials
Digital Health & AI
- Artificial intelligence algorithms
- Digital therapeutics
- Remote patient monitoring
- Health information systems
Quality Assurance Excellence
Regulatory-Grade Quality Control
- Subject matter expert review
- Back-translation verification
- Linguistic and medical validation
- Regulatory compliance checking
- Multi-stage proofreading process
Specialized Review Process
- Medical doctor review for clinical content
- Pharmacist review for drug information
- Regulatory affairs specialist validation
- Patient safety impact assessment
- Risk-based quality management
Confidentiality & Data Security
Protecting sensitive patient data and proprietary research is paramount. Tarjim employs stringent security protocols, including comprehensive NDAs and GDPR/HIPAA compliance, to ensure your confidential information remains secure throughout the translation process.
Protecting Sensitive Information
- Comprehensive NDAs and confidentiality agreements
- HIPAA and GDPR compliance
- Secure file transfer and storage systems
- Access controls and audit trails
- Clinical data privacy protection
Advance Healthcare Globally
Partner with Tarjim to bring life-saving treatments and medical innovations to patients worldwide. Contact us for life sciences translation that meets the highest standards of accuracy, compliance, and patient safety.