Compliance & Quality
Unwavering commitment to regulatory compliance, quality assurance, and ethical business practices
Compliance Excellence
Oracle BioTech maintains the highest standards of regulatory compliance across all operations, ensuring adherence to GCP, GMP, and international quality standards while upholding ethical business practices.
Quality Management System
Comprehensive quality management system ensuring consistent delivery of high-quality services and compliance with global regulatory standards.
- ISO 13485 certified
- GCP/GMP compliance
- Risk-based quality approach
- Continuous improvement
Regulatory Compliance
Proactive compliance monitoring and management ensuring adherence to evolving regulatory requirements across global markets.
- FDA/EMA compliance
- ICH guidelines adherence
- Data integrity standards
- Audit readiness
Our Compliance Framework
Good Clinical Practice
Strict adherence to GCP guidelines ensuring the highest standards of clinical trial conduct and data integrity.
Good Manufacturing Practice
GMP-compliant manufacturing and quality control processes ensuring product safety and efficacy.
Data Integrity
Robust data integrity controls and electronic systems validation ensuring accurate and reliable data.
Ethics & Integrity
Comprehensive ethics program promoting integrity, transparency, and responsible business conduct.
Risk Management
Proactive risk identification and mitigation strategies ensuring operational resilience and compliance.
Quality Metrics
Continuous monitoring and measurement of quality indicators driving performance improvement initiatives.