DEFINING STRATEGY

The Path to Success

MANAGEMENT COMMITMENT

Required for Sustainable Compliance

ARCHES Consulting Services

Whether you are a large pharmaceutical company dealing with regulatory complexities across the globe, or a small to medium sized company trying to keep up with growing pains and evolving regulations, we can help you improve your quality systems processes and operations to ensure sustainable compliance.

Services

Development of Effective Training Program

CAPA Management and effectiveness evaluation

Supplier Management, audit and Qualification

Deviation, Change Control and Complaint Management

Quality Systems

Remediation for FDA Warning Letter and 483 observations. GAP assessment and Quality System Remediation.

Process Validation

Development of Process Validation strategy and Process Validation protocols. Process validation oversight and Report preparation

Cleaning Validation

Development of Cleaning Validation strategy, Master Cleaning Validation Plan and Protocols. Cleaning Validation execution, oversight and Report preparation