Regulatory-Grade Life Sciences Translation & Medical Validation
Zero-error linguistic solutions for Pharma, Biotech, and MedTech. From Clinical Trial Protocols to SFDA submissions, we provide the technical precision required to ensure patient safety and global compliance.
Critical Role of Life Sciences Translation
In the Life Sciences, linguistic ambiguity is a regulatory hazard. A single mistranslated dosage or protocol doesn’t just delay market entry; it creates catastrophic patient risk and legal liability. Tarjim provides Regulatory-Grade Validation, utilizing MD-level linguists and back-translation protocols to ensure your dossiers, IFUs, and clinical trials are audit-proof and clinically absolute. We don’t just translate; we safeguard your path to global approval.
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
In Life Sciences, data leakage isn’t just a breach; it’s a terminal threat to your Intellectual Property. Tarjim operates a fortified data environment where confidentiality is baked into the infrastructure. By combining bank-grade encryption, HIPAA/GDPR-compliant workflows, and project-specific NDAs, we ensure your proprietary research and sensitive patient data are shielded at every touchpoint. We provide the security of an in-house lab with the scale of a global agency.
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.
FAQ'S
1. How do you guarantee the accuracy of high-stakes clinical protocols?
In the medical field, “close enough” is a hazard. We utilize a Double-Blind Back-Translation process. A medical subject matter expert translates your document into the target language, and a second, independent expert translates it back into the original. We then reconcile any semantic shifts to ensure the scientific meaning is 100% preserved and ethically sound.
2. Are your services compliant with SFDA and UAE Ministry of Health regulations?
Yes. We specialize in Regional Regulatory Affairs. We don’t just translate; we localize dossiers, SmPCs (Summary of Product Characteristics), and labeling to meet the specific linguistic and formatting mandates of the Saudi Food and Drug Authority (SFDA) and the UAE Ministry of Health (MOH), ensuring your submission is audit-ready from day one.
3. How do you protect sensitive patient data and proprietary IP?
Data integrity is our primary directive. We operate within a HIPAA and GDPR-compliant framework, utilizing bank-grade encryption for all file transfers. Every linguist is bound by project-specific NDAs, and for highly sensitive patent research, we offer Zero-Retention workflows to ensure no digital footprint remains after project delivery.
4. Can you localize "Software as a Medical Device" (SaMD) and AI health apps?
Absolutely. We provide ISO 13485-aligned localization. We ensure that UI/UX elements, safety warnings, and error messages are linguistically precise and culturally adapted for healthcare professionals and patients alike, preventing user-error and maintaining the clinical efficacy of your digital health tools.
5. Are your translators actually medical professionals?
Our Life Sciences desk is comprised of Subject Matter Experts (SMEs), including MDs, PhDs, and Pharmacists. They don’t just know the vocabulary; they understand the methodology. This ensures that the “medical register” of your documentation is professional, authoritative, and scientifically accurate.