
by IQVIA
Unified regulatory submissions, registrations, and lifecycle management to accelerate global market access.
Quality, Compliance & Regulatoryby Orcanos
Unified quality management and application lifecycle management for medical device development, with automated traceability, risk management, and audit readiness.
Quality, Compliance & Regulatoryby Orcanos
Traceability matrix management across ALM and QMS artifacts with impact analysis and multi-level reporting.
Quality, Compliance & Regulatoryby Orcanos
Defect tracking and reporting integrated with requirements and test management for quality assurance teams.
Quality, Compliance & Regulatoryby Orcanos
Change control and document management across the product lifecycle with automated approvals, audit trails, and compliance tracking.
Quality, Compliance & Regulatoryby Orcanos
Post-market surveillance and complaint management with MDR compliance, integrated with quality and design control workflows.
Quality, Compliance & Regulatoryby Orcanos
AI-powered traceability assistant that generates intelligent suggestions for risk assessments, test cases, and CAPA analysis in medical device development.
Quality, Compliance & Regulatory
by Certivo
FDA 21 CFR Part 11 compliant electronic signatures with ALCOA+ audit trails and 25-year retention for clinical trials and regulated life sciences.
Quality, Compliance & Regulatory
by InfoEd Global
IRB, IACUC, environmental safety, and conflict of interest management for research compliance and ethics oversight.
Quality, Compliance & Regulatoryby Verifarma
Pharmaceutical serialization and supply chain traceability with GS1 standards, regulatory reporting, and multi-level aggregation.
Quality, Compliance & Regulatoryby Verifarma
Centralized quality management for deviations, CAPAs, audits, and documentation with full traceability and regulatory compliance.
Quality, Compliance & Regulatoryby Verifarma
Centralized management of regulatory records, dossiers, and documentation with complete traceability and global compliance for pharmaceutical companies.
Quality, Compliance & Regulatoryby DDi
Regulatory information and process management for pharma, medical devices, and life sciences organizations.
Quality, Compliance & Regulatoryby DDi
Electronic Instructions for Use (eIFU) management for medical devices with EU MDR, FDA 21 CFR Part 11, and global regulatory compliance.
Quality, Compliance & Regulatoryby DDi
Master data management and regulatory validation for global UDI compliance, EUDAMED submission, and FDA GUDID across multiple health authorities.
Quality, Compliance & Regulatoryby DDi
Regulatory monitoring, alerting, and impact assessment for pharma and medical device companies across global markets.
Quality, Compliance & Regulatoryby DDi
AI-driven workflow automation and agentic process optimization for enterprise operations, with governance and compliance controls.
Quality, Compliance & Regulatory
by Juleb
Warehouse mobility and drug track & trace compliance for pharmaceutical distribution and retail operations.
Quality, Compliance & Regulatory
by Juleb
Drug track and trace reporting for FDA DSCSA compliance with real-time ERP integration and package aggregation.
Quality, Compliance & Regulatoryby DrugCard
eCTD dossier creation and submission for medicinal product registration, fully compliant with Ukraine's 2025 standards.
Quality, Compliance & Regulatory