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Quality Investigation
Quality Investigation & CAPA Support
Ensuring Compliance & Continuous Improvement
At Isha’s GMP, we specialize in Quality Investigations and Corrective and Preventive Action (CAPA) support to help pharmaceutical, biotech, and medical device companies maintain regulatory compliance and operational excellence.
Our Quality Investigation & CAPA Services:
Root Cause Analysis & Investigation
- Structured approach to identifying root causes of discrepancies
- Expert support in manufacturing, testing, & distribution investigations
- Addressing product complaints & quality issues
Corrective & Preventive Action (CAPA) Implementation
- Development of effective, risk-based CAPA plans
- Implementation of preventative measures to stop recurrence
- Regulatory-compliant CAPA documentation & reporting
Regulatory Compliance & Support
- Aligning investigations with GMP regulations & industry guidelines
- Support in defending CAPA systems to regulatory agencies
- Assistance with audit preparation & compliance remediation
Custom Investigation & CAPA Program Development
- Optimization of existing quality systems
- Building a new investigation framework tailored to your organization
- Integration of subject matter expertise across various disciplines
Why Choose Isha’s GMP for Quality Investigations?
- Industry-leading experts with global regulatory experience
- Hands-on experience in API, drug substance, drug product & medical devices
- Comprehensive CAPA solutions for long-term compliance & improvement
- Flexible engagement – we integrate with your team or build systems from scratch
Need expert Quality Investigation & CAPA support? Contact Isha’s GMP today!