BioQA Solutions, LLC

• cGMP Quality System Consulting
• Medical Devices
• Pharmaceuticals
• Biopharma(ceuticals)
• Combination Products

• ISO 13485:2016 Medical Device QMS Certification Preparation (in support of CE marking)

•  Audits (ASQ-CQA certified)

• Internal
• Supplier Qualification
• Hosting of Regulatory Agencies and Notified Bodies

•  Quality Management System (QMS) Review

• Gap Analysis
• Action Plan

•  CAPA:Corrective & Preventative Action

•  Training

*but are not limited to