Regulatory Compliance
Ensure compliance across
global regulatory frameworks
Built-in compliance with global regulatory requirements for pharmaceutical research and market access
Global Regulatory Compliance
CDSCO Guidelines:Full compliance with Central Drugs Standard Control Organization
Ethics Committee Coordination:Streamlined ethics committee approvals
Clinical Trial Registry:Integration with International Clinical Trial Registries
Pharmacovigilance Compliance:Automated adverse event reporting to regulatory authorities
International Standards
ICH-GCP Compliance:International Conference on Harmonisation Good Clinical Practice
FDA Guidance:Compliance with US FDA guidelines for clinical trials and real-world evidence
EMA Requirements:European Medicines Agency requirements for market authorization
WHO Standards:World Health Organization guidelines for clinical research
Data Protection & Privacy
GDPR Compliance:European data protection regulation compliance
HIPAA Alignment:Health Insurance Portability and Accountability Act compliance
Local Privacy Laws:Compliance with international data protection regulations
Cross-Border Data Transfer:Secure and compliant international data transfer
Quality Management
ISO 14155 Compliance:Clinical investigation of medical devices compliance
21 CFR Part 11:Electronic records and signatures compliance
GxP Standards:Good practices for pharmaceutical quality management
Risk-Based Monitoring:ICH E6(R2) compliant risk-based monitoring approach
Regulatory Services
Regulatory Consulting
Expert guidance on regulatory strategy and compliance
Submission Support
Assistance with regulatory submissions and applications
Audit Readiness
Continuous audit readiness with comprehensive documentation
Global Harmonization
Ensure compliance across multiple regulatory jurisdictions
Compliance Benefits
Reduced Regulatory Risk
Minimize risk of regulatory delays or rejections
Faster Approvals
Streamlined regulatory processes and faster approvals
Global Market Access
Simultaneous compliance with multiple regulatory frameworks
Cost Optimization
Reduced compliance costs through automation and integration