Collaborators
Anastasia Lolas, MS
President, Visionary Pharma Consulting LLC
Advice on regulatory and compliance issues for CMC microbiology (NDAs, ANDAs & BLAs). Mock inspections, due diligence, gap analysis, remediation, product quality microbiology, and supplier audits.
Review of the Chemistry, Manufacturing and Controls section of regulatory drug and biologic applications submitted to the Food and Drug Administration (terminal sterilization, aseptic fill, sterile and non-sterile products). Over 250 reviews completed while at the FDA.
Former FDA investigator conducting pre-license and pre-approval inspections of therapeutic protein manufacturing facilities.
Interested in Quality by Design, lean manufacturing, process control, sampling plans, microbial control, sterilization, aseptic processing, biofilms.
Specialties: Compliance, cGMP, audits, mock inspections, biotech products, aseptic processing, CMC microbiology, remediation