Welcome to Quality Compliance Solutions, LLC
Your provider of quality
and compliance services!
About Us
Expert in Drug Supply Chain Security Act (DSCSA)
- Standardized Numerical Identification (SNI) quality management for commissioning, decommissioning, and destruction
- Labeling lifecycle review
- Policy & SOP technical writing
Expert in Supply Chain
- ASQ Certified Quality auditor
- Experienced in 21 CFR Part 205
- Supplier auditing (APIs, excipients, and components)
- Contract manufacturer and packager auditing
- Supplier qualification program management
- ERP quality management
- Quality agreement technical writing
- Reverse logistics program management
- Recall program management
- Verified-Accredited Wholesale Distributors® (VAWD®) preparedness plans
Expert in Current Good Manufacturing Practices (cGMP)
- Over 20 years pharmaceuticals experience in solids, semi-solids, solutions, and medical devices
- Experienced in 21 CFR Parts 11, 210, 211, 807, and 820
- Experienced in ICH Q7 and Q10
- Experienced in policy & SOP technical writing
- Skilled in investigation technical writing