Starsiak Consulting provides professional QA contract consulting services to its pharmaceutical and medical device clients to ensure compliance with FDA cGMP and QSR regulations. 

Services include custom development of quality system SOPs, cGMP compliance audits, full-service quality assurance functionality, and QA support for an individual task or project. 

Our comprehensive knowledge and experience, combined with our efficient and effective work practices will give you the results you need within your desired timeframe.

Areas of Expertise

• Quality Assurance
• Quality Systems
• FDA cGMP Compliance
• Internal Audits
• Supplier Audits
• Mock PAI Audits
• Due Diligence
• SOP Development
• Document Management
• Manufacturing QA
• Laboratory Compliance
• Quality Control
• Microbiology
• Warehouse Controls
• Complaint Management
• Validation
• Regulatory Compliance
• Prescription Products
• OTC Drug Products
• Cosmetics
• Medical Devices
• Dietary Supplements
• Clinical Manufacturing
• Commercial Operations

Call Us Today!

Please contact us to discuss your specific QA business needs.

Michele Starsiak, Principal QA Consultant

San Diego Office: 619.520.5210

starsiakconsulting@att.net