FOR REGULATORY, COMPLIANCE, AND QUALITY TEAMS
Multilingual AI to Power Regulatory Compliance
Ensure every translation meets the highest standards of accuracy, traceability, and accountability to support drug submissions and accelerate time-to-market. LILT delivers compliant multilingual workflows—aligned with new EU AI legislation for pharma—powered by adaptive AI, audit-ready reporting, and expert human oversight.
The LILT Difference
Audit-Ready Translation Workflows
Maintain full traceability with version control, edit histories, and approval logs that meet FDA, EMA, ISO, and SOC 2 requirements.
Compliance-Aligned AI Models
Use adaptive AI trained for regulated environments to ensure precision, consistency, and compliance—LILT models are never shared, keeping sensitive data private and secure.
Human-Verified Accuracy
Combine AI efficiency with optional expert linguistic review, with therapeutic area expertise, for critical or regulated content to ensure every translation is defensible and audit-compliant.
Secure, Controlled Deployments
Deploy in SaaS, hybrid, or air-gapped environments that align with your internal data governance, security, and retention policies.
Integrated to Regulatory Workflows
Ability to connect directly to RIM and PLM systems automate translation within existing labeling and submission workflows.
Use Cases
Regulatory Filings and Submissions
Translate and validate submission dossiers to authorities like EMA, FDA, PMDA, and MHRA with traceable, version-controlled workflows.
Labeling
Translate labeling, Instructions for Use (IFUs), SmPCs, PILs, and regulatory correspondence within strict Health Authority timelines.
Compliance & Policy Documentation
Localize codes of conduct, policies, and compliance manuals while maintaining fidelity to original regulatory language.
Quality and Audit Reports
Ensure accurate, compliant translations of inspection findings, quality summaries, and CAPA documentation.
Risk & Incident Reporting
Translate safety alerts, compliance notifications, and internal incident reports rapidly while maintaining auditability.
Cross-Border Regulatory Communication
Support regulators, auditors, and global partners with accurate multilingual reports and filings.
Benefits
Maintain Full Compliance
Align multilingual workflows with FDA, EMA, MHRA, ISO, and SOC 2 Type II standards.
Ensure Audit Readiness
Capture every translation change, approval, and reviewer action with complete transparency.
Improve Accuracy in Regulated Content
Combine AI precision with human validation for labeling content and critical materials.
Protect Sensitive Data
Deploy in secure, compliant environments that meet your organization’s governance and privacy standards.
Simplify Oversight
Centralize compliance translation management across teams, vendors, and regions.