- Quality Management
- 483s and Consent Decree Remediation
- Periodic System and Facilities Reviews
- Contract Lifecycle Management
- Validation Master Plans
- Gap Analysis
- Technology Transfers
- Equipment and Facilities/Utilities Decommissioning
- Test Methods Validation
- Cleaning Validation
- Computer System Validation
- Process Validation
Governance, Regulatory & Compliance Services
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REGULATORY COMPLIANCE, GOVERNANCE
When you're working in a tightly-regulated industry, compliance should come first. You must ensure that the necessary processes are in place to stay compliant while maintaining operational output. Our team of experts has the necessary experience to make sure compliance is integrated throughout your processes, eliminating costly risks and maximizing your efficiency.
We offer services for every step of the compliance process. We're able to provide quality management and a complete gap analysis to help you make strategic decisions about compliance. If you've had or are experiencing a compliance issue, we provide remediation services for 483s, and consent decrees. When a regulatory project overwhelms you, we can step in to help you salvage it.