site by
QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES

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
 
 
Evaluation
 
GMP & QSR Auditing
Contract Manufacturing
Quality System Productivity
Organization and Qualifications
Due Diligence
FDA Preparation & Mock Audits
Risk Analysis
 
 
 
Planning
 
Quality Plan
Compliance Master Plan
Validation Master Plan
Management Action Plan
 
Crisis Management (Strategy & Support)
 
FDA Issues
Emergencies
Negative Trends
Product Quality
Emerging Problems
 
 
Laboratory Support
 
Method Validation
Method Transfer
Laboratory Operations
GMP Compliance
Records
 
 
Validation
 
Validation Master Plan
Process Validation
Packaging Validation
Cleaning Validation
Equipment IQ, OQ, PQ
Test Method Validation
 
 
Documentation
 
Quality Systems & Procedures
Specifications
Master Records
Systems
Templates
 
 
 
  

 

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”.