Representative Consulting Projects

Conduct cGMP and ICH compliance assessment of global pharmaceutical company commercial product drug product stability program and analytical procedure validation for global generic drug products, and then develop and execute remediation plan.  

Conduct mock FDA PLI/PAI audit and inspection readiness assessments for drug substance and drug product biologic manufacturers.  

Create QC operations and systems procedures such as conducting non-conformance and OOS investigations, raw material qualification, managing reference materials/standards, and reserve samples.  

Conduct supplier audits of contract testing laboratories.  

• Write BLA Module 3 sections for biologic drug product and drug substance. 
• Write CMC sections for BLA and NDA annual reports

• Interim QC Director for biotechnology company focused on development and commercialization of therapeutic live-virus vaccines. 
• Oversight of clinical and commercial drug product and bulk drug substance (API) lot release and stability studies conducted at contract laboratory for client, including review for technical and GMP compliance and investigation of non-conformance and OOS events.