Clinical sites bear median regulatory compliance costs of $3,750 per study, frequently exceeding reimbursements of $3,000.
Stop waiting on paper. Our platform slashes regulatory submission times and guarantees inspection readiness. Giving Sponsors, Sites, and Investigators the speed and confidence to accelerate trial success. Harness AI-driven tools for CMC, pharmacovigilance, submissions, and data standards to fast-track therapies from lab to market. Seamlessly integrate e-signatures, analytics, and validation for unmatched compliance confidence and operational speed.
Our Solutions
Our Regulatory Automation suite is built on the principle of efficiency meeting compliance, turning administrative hurdles into competitive advantages.
Automate Chemistry, Manufacturing, and Controls data extraction for eCTD Module 3 authoring and annual reports from QMS/LIMS systems.
- Interactive Process Flow Diagrams (PFDs)
- Stability trend analysis
- Full traceability matrices
- FDA validation readiness
Perform AI-powered search across FDA deficiency letters, guidance documents, and regulations for rapid compliance responses.
- Natural language queries
- Real-time result ranking
- Citation export functionality
- Deficiency letter pattern analysis
Streamline adverse event reporting, signal detection, and MedDRA coding for global pharmacovigilance compliance.
- Automated case processing
- Real-time signal monitoring
- Cross-jurisdiction mapping
- E2B(R3) export capabilities
Transform eCRF data into compliant CIOMS narratives and regulatory reports using AI-driven natural language generation.
- Patient-level narrative creation
- Standardized medical phrasing
- Multi-language support
- Version control & audit trails
Automate Drug Enforcement Administration license verification and controlled substance compliance checks.
- Bulk license validation
- Expiration date monitoring
- 70% cost reduction
- Real-time status dashboards
Digitize Institutional Review Board submissions, amendments, and approvals with workflow automation and e-signatures.
- Standardized templates
- Automated routing & reminders
- Comprehensive audit trails
- Real-time approval tracking
AI-powered identification and removal of PII, PHI, and sensitive data across regulatory documents.
- HIPAA/GDPR/EMA compliance
- Context-aware redaction
- Bulk processing capabilities
- Pre- and post-redaction validation
Unified platform for Lot Distribution Reports, SPL generation, label validation, and eCTD pre-flight checks.
- FDA/EMA gateway validation
- Automated XML formatting
- Artifact hierarchy verification
- Multi-region submission support
Enable secure, legally binding e-signatures to streamline document approvals while ensuring regulatory compliance.
- Legally binding e-Signatures
- Secure authentication
- Automated notification flows
- Audit-ready time stamping
Bridge the gap between your clinical data and global regulatory standards with an automated mapping engine.
- Automated CDISC SDTM mapping
- Real-time data validation
- Cross-study standardization
- Instant analytic dashboards for safety/efficacy
Key Benefits
Our Regulatory Automation platform delivers targeted benefits that ensure every stakeholder achieves their critical objectives with speed and certainty.
Our Regulatory Compliance Automation platform delivers measurable advantages that empower every stakeholder—from regulatory teams to clinical operations—with precision, speed, and compliance assurance.
Risk Mitigation: Maintain immutable audit trails and compliant e-signatures across all workflows, minimizing regulatory findings and avoiding costly trial disruptions.
Real-Time Compliance Access: Centralize CMC, pharmacovigilance, and submission documents for instant, verifiable inspection readiness anytime.
Slash Processing Times: Automate eCTD Module 3 authoring, narrative generation, and pre-flight validations to eliminate manual errors and speed FDA/EMA filings.
Resource Optimization: Free up high-value personnel (Site Coordinators, CRAs, Regulatory Affairs Staff) from repetitive tasks like DEA checks and document redaction, enabling focus on strategic priorities.
Secure Global Collaboration: Implement Secure Document Exchange (DocXchange) to share sensitive trial data with internal teams and external partners (CROs, Sites) with full security, traceability, and controlled access. Data Integrity Assurance: Leverage AI-driven classification, redaction, and validation to ensure every document meets HIPAA/GDPR/EMA standards from upload.
Cost Reduction: Cut expenses by 70% on validations (e.g., DEA) and manual processing, avoiding remediation fees and storage overheads.
Rapid ROI: Compress submission timelines by weeks, accelerating therapies to market and maximizing R&D investment returns.
Submission Perfection: Guarantee regulator-ready formats for SPL, LDR, and CIOMS reports, eliminating rejection risks and last-minute fixes.
Proactive Insights: Get standardized, real-time visualizations of your trial’s health with earlier identification of safety signals and take faster strategic decisions to prevent costly mid-course corrections.
Organizations using unified data platforms (integrated eTMF/eISF solutions) report 45% faster site activation compared to manual processes.
The average cost of non-compliance for a company is 2.71 times more costly than the cost of implementing compliance measures.
The regulatory oversight market, driven by compliance automation, is projected to reach $32.2 billion by 2029, reflecting a Compound Annual Growth Rate (CAGR) of 8.7%.
Implementing a validated eSignature system can lead to completing 70% of eSignatures within 24 hours.
Ready to achieve 100% inspection readiness and cut your submission timelines by months?