Before translation begins, we help organizations assess and optimize clinical instruments through:
- COA source validation
- Face validation with expert review
- Patient interviews
- Readability testing
- Translatability assessments
Regulatory Affairs & Life Sciences
Supporting Global Healthcare Innovation with Confidence
Life sciences organizations operate in highly regulated global markets where accuracy, compliance, and speed are critical. Translate.One helps pharmaceutical, biotechnology, medical device, and healthcare companies manage multilingual content throughout the product lifecycle, ensuring regulatory compliance and clear communication across every market.
By combining life sciences expertise, ISO-certified quality processes, advanced technology, and global language capabilities, we help organizations bring products to market faster and with confidence.
End-to-End Life Sciences Support
Our services extend beyond translation. We help organizations manage the complex content, regulatory, and compliance requirements associated with global healthcare products.
COA Source Validation
Strong outcomes begin with strong source content.
By identifying issues early, organizations can reduce downstream costs, improve patient comprehension, and support regulatory expectations around patient involvement.
COA Licensing Support
Managing copyrighted clinical outcome assessments can be complex and time-consuming.
Our team provides end-to-end support for:
- Identifying copyright holders
- Obtaining required licenses
- Tracking permissions
- Sourcing certified translations
- Managing licensing payments and administration
This allows sponsors and CROs to focus on study execution while we manage the administrative complexity.
Regulatory Submission Management
Global submissions require precision, consistency, and speed.
We support the translation and management of regulatory documentation for:
- New Drug Applications (NDAs)
- Marketing Authorization Applications (MAAs)
- Regulatory correspondence
- Annual reports
- Study reports
- Risk management plans
- Product labeling
- Packaging content
- PSURs and safety documentation
Our teams help organizations maintain compliance across multiple regulatory authorities and international markets.
Medical Device & IVD Solutions
Medical device manufacturers face increasingly complex regulatory obligations under MDR and IVDR frameworks.
Translate.One provides specialized support for:
- Instructions for Use (IFUs)
- Packaging and labeling
- Regulatory submissions
- Software localization
- Field safety notices
- Post-market surveillance documentation
- In Vitro Diagnostic (IVD) content
Our ISO 13485-certified processes help ensure quality, traceability, and compliance throughout the localization lifecycle.
IFU Compliance Review (MDR/IVDR)
Errors in source Instructions for Use can create costly challenges when content is localized into multiple languages.
Our compliance review services help identify issues before localization begins by assessing:
- MDR and IVDR compliance
- Clarity and usability
- Content consistency
- Regulatory alignment
Addressing issues at the source reduces risk, improves quality, and minimizes costly rework.
Pharmacovigilance & Safety Translation
Patient safety depends on accurate and timely communication.
We provide rapid translation and language support for:
- Serious Adverse Events (SAEs)
- SUSARs
- Safety narratives
- Literature reviews
- Safety reports
- Medical information requests
- Pharmacovigilance communications
Our teams understand the urgency and precision required for safety-critical content.
Technical Authoring & Readability Optimization
Translation quality begins with source content quality.
We help organizations improve content before localization through:
- IFU authoring
- Readability assessments
- Native-language checks
- Technical editing
Clear, well-structured source content improves patient comprehension, reduces translation costs, and enhances regulatory compliance.
