Regulatory
Regulatory Translation Services
Professional translation services for pharmaceutical regulatory documentation,
ensuring compliance with Hungarian and EU requirements
Product Documentation
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflets (PIL)
- Package Leaflets
- Product Labels
Compliance Documents
- Non-disclosure agreements
- Data protection documentation
- GDPR-related materials
- Regulatory correspondence
Marketing Authorization
- Authorization applications
- Variation documentation
- Safety updates
- Local authority submissions
Why Choose My Regulatory Translation Services?
- Deep understanding of Hungarian regulatory requirements
- Experience with EMA and local authority guidelines
- Strict terminology consistency across all documents
- Knowledge of regulatory submission processes
- Attention to detail in compliance-critical content