(c)GMP ICH Q7/Q11 Regulatory Consulting
The Saxon Interglobal Associates sphere of experienced resources can help you with a comprehensive knowledge of regulatory requirements for (c)GMP ICH Q7/Q11.
We can identify your (c)GMP ICH Q7/Q11 Regulatory Compliance requirements and help you create the most cost-effective and risk-averse strategies and practices in a deliverable plan for pre-inspection implementation.
Saxon Interglobal Associates offers (c)GMP ICH Q7/Q11 Regulatory Consulting assistance in the following areas:
-Assessment for (c)GMP ICH Q7/Q11 Auditing Requirements
-Pre-Inspection Evaluation and Preparation for Proper Audit Procedures:
Facilities
Personnel
Equipment
Components, Containers and Closures
Production and Process Controls
Packaging and Labeling Control
Holding and Distribution
Laboratory Controls
Documentation
Returned and Salvaged Products
-(c)GMP Auditing Requirement Recommendation and Deliverables