Starsiak Consulting provides professional contract quality leadership and Quality Assurance consulting services to its pharmaceutical, medical device, biologics, cosmetics and dietary supplement clients to ensure compliance with FDA CGMP and QSR regulations. 

Services include quality leadership, strategic direction, custom development of quality systems, SOPs/Forms, internal/external GxP compliance audits, full-service quality assurance functionality, quality system management, or 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 Leadership
• Quality Systems Design
• Quality Systems Management
• FDA CGMP Compliance
• Commercial CGMP Quality
• Clinical CGMP Manufacturing
• Internal Audits
• Supply Chain Audits
• API Audits
• Mock PAI Audits
• Due Diligence Audits
• GxP Vendor/Supplier Audits
• Quality Manual Development
• SOP/Form Development
• Document Management
• Manufacturing QA
• Packaging/Labeling QA
• Laboratory Compliance
• Quality Control
• Microbiology
• Warehouse Controls
• Complaint Management
• Validation Review
• Regulatory Compliance
• Pharmaceuticals
• Prescription Drug Products
• OTC Drug Products
• Cosmetics
• Medical Devices
• Dietary Supplements
• Change Control
• Deviations
• Nonconforming Material
• CAPA
• CMC Review
• Specifications
• Master Batch Records
• Batch Record Review

Contact Information:

Please contact us to discuss your specific QA business needs.

Michele Starsiak, President/Principal GXP Quality Assurance Consultant

San Diego Office: 619.520.5210

starsiakconsulting@att.net