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Our Mission | Our Approach | Areas of Services | Advantages
Our Mission
The Spyglass Group Quality and Compliance Division is committed to be the consulting group of choice for our clients by providing proactive and sustainable solutions which enable our clients to meet FDA compliance regulations and world-class quality standards.
Our Approach
Areas of Services
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Evaluation
GMP & QSR Auditing
Contract Manufacturing
Quality System Productivity
Organization and Qualifications
Due Diligence
FDA Preparation & Mock Audits
Risk Analysis
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Planning
Quality Plan
Compliance Master Plan
Validation Master Plan
Management Action Plan
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Crisis Management (Strategy & Support)
FDA Issues
Emergencies
Negative Trends
Product Quality
Emerging Problems
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Laboratory Support
Method Validation
Method Transfer
Laboratory Operations
GMP Compliance
Records
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Validation
Validation Master Plan
Process Validation
Packaging Validation
Cleaning Validation
Equipment IQ, OQ, PQ
Test Method Validation
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Documentation
Quality Systems & Procedures
Specifications
Master Records
Systems
Templates
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SpyGlass Group Advantages
Team of Experts…
Over 150 years combined experience in NDA and OTC drugs, Medical Devices and Consumer Products.
Collaboration…
SpyGlass Group joins forces with your in-house experts to offer objective analysis and solutions. Importantly, our multidisciplinary SpyGlass Expert Panel provides a continual "sounding board" for questions, strategies, plans, etc. Our clients and consultants are never alone in tackling a challenging assignment.
Customized Solutions…
The SpyGlass Group consistently incorporates risk-based thinking and offers practical and sustainable solutions. We make sure that the “right things are done right”.
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