At
Lean Pharma Services, we are committed to delivering high-quality
pharmacovigilance, medical governance, medical information, and quality management services by ensuring compliance with international standards, regulations, and best practices.
Key Principles :
- Customer Focus: We prioritize regulatory requirements, patient safety, and stakeholder needs.
- Process Improvement: We continuously refine vigilance, medical governance, and quality processes using data-driven decisions.
- Regulatory Compliance: We adhere to ICH, FDA, EMA, ISO 9001:2015, and ISO 27001:2022, and to other Laws and Regulations to maintain research and safety integrity and compliance of the company operation.
- Employee Competence: We foster a culture of continuous learning, skill development, and compliance awareness.
- Risk-Based Approach: We implement proactive risk assessment methodologies to manage compliance risks effectively.
Objectives :
- Ensure 100% compliance with vigilance, medical information, and governance regulations.
- Maintain zero tolerance for data integrity breaches.
- Improve process efficiency in safety reporting and information handling.
- Achieve continuous improvement through audits, training, and corrective actions.
Effective: 20-Jun-2025