Quality Systems Development

Quality System Development, Implementation Support 

Supplier / Vendor Management and Remediation 

Audit and Assessments 

Deviation Investigations / CAPA / RCA 

Manufacturing Compliance Oversight 

QA Management Responsibilities 

SOP/Procedure Development and Review 

Batch Record Review and Approval 

Risk Management 

Change Control Program 

FDA 483 Response Support 

CAPA Development/Support 

Quality Manual Development 

Vendor/Supplier Qualification 

Project Management 

Validation Review 

Equipment / Utility / Process Validation 

IND/NDA/BLA Review 

CMC Review/Development