Trusted by Top Companies
Regulatory Intelligence Agent
Utility:
An AI agent that scans global regulatory agency websites (FDA, EMA, PMDA, etc.), publications, and databases, then provides automated alerts, summaries, and actionable insights about regulatory updates, guidance documents, and compliance requirements.
Use Cases:
- Early detection and notification of new regulations or changes.
- Automated synthesis of regulatory intelligence for fast decision-making.
- Gap analysis between existing documentation/processes and new regulatory guidelines.
AI-enabled Regulatory Submission Reviewer
Utility:
An AI agent that analyzes and reviews regulatory submission documents such as IND, NDA, CTA, PMA, IDE, and other dossier contents, flagging inconsistencies, missing elements, or deviations from regulatory guidelines.
Use Cases:
- Reducing submission rejection risks by pre-submission review.
- Enhancing compliance through automated validation against FDA or EMA submission checklists.
- Faster submissions by automating repetitive compliance tasks.
Automated Regulatory Document Generator
Utility:
An AI-driven tool that generates accurate, compliant regulatory documents, such as clinical study reports (CSRs), investigator brochures (IBs), clinical protocols, and informed consent forms (ICFs), leveraging Natural Language Generation (NLG) from structured clinical data.
Use Cases:
- Accelerated preparation of standard regulatory documents.
- Reduction in human error through automated data extraction and document drafting.
- Standardization across documentation for regulatory consistency.
AI-powered Regulatory Compliance Auditing Assistant
Utility:
An intelligent agent that autonomously reviews processes and systems against regulations (ICH GCP, FDA CFR Part 11, EMA Annex 11, ISO 13485) by analyzing internal SOPs, validation documents, and system logs.
Use Cases:
- Continuous compliance monitoring with automated risk assessments.
- Pre-audit inspections with proactive identification of compliance gaps.
- Documentation and evidence gathering for inspections.
.svg)
Intelligent Labeling and Artwork Management Assistant
Utility:
An AI solution that automatically validates and cross-checks packaging labels, promotional materials, and patient information leaflets (PILs) against approved regulatory texts, helping companies avoid costly errors and recalls.
Use Cases:
- Automated proof-reading of regulatory texts in product labels.
- Ensuring compliance with labeling regulations for different global markets.
- Facilitating rapid approval cycles by minimizing labeling errors.
AI-driven Post-market Surveillance(PMS) Utility
Utility:
An AI-driven system that autonomously monitors adverse event reports, consumer complaints, clinical literature, social media, and regulatory databases, identifying safety signals and automatically initiating regulatory submissions (such as PSURs, DSURs, MDR submissions).
Use Cases:
- Early identification and reporting of potential safety concerns.
- Automation of regulatory submissions required for PMS compliance.
- Enhanced decision-making based on real-time safety insights.
Intelligent Clinical Trial Disclosure Assistant
Utility:
An AI tool that manages clinical trial disclosure requirements (ClinicalTrials.gov, EudraCT, etc.), automatically generating compliant postings and timely updates from clinical data and study documents.
Use Cases:
- Reducing errors and omissions in clinical trial registry submissions.
- Timely compliance with transparency and disclosure mandates.
- Automated generation of lay summaries and technical abstracts.
AI-Driven Inspection Readiness Assistant
Utility:
An intelligent agent that proactively assesses organizational readiness for FDA, EMA, or other regulatory inspections by analyzing document completeness, process adherence, data integrity, and past inspection findings.
Use Cases:
- Automated inspection preparedness reports and dashboards.
- Real-time tracking of inspection readiness metrics.
- Recommendations and corrective action management.
Intelligent Regulatory Query Management Assistant
Utility:
An AI assistant that intelligently handles queries from regulatory bodies by automatically preparing accurate and comprehensive responses, utilizing deep learning trained on previous interactions and regulatory documentation.
Use Cases:
- Accelerating regulatory query responses.
- Enhancing accuracy and consistency of query management.
- Documenting and tracking query response timelines and outcomes.
AI-enabled Regulatory Training & Knowledge Base Agent
Utility:
An interactive AI assistant that provides personalized training and real-time answers to regulatory questions, referencing current guidelines, historical precedents, and internal policies.
Use Cases:
- Rapid onboarding and training of regulatory personnel.
- Continuous learning and compliance reinforcement.
- Instant access to regulatory knowledge, reducing errors in routine tasks.
