Anastasia Lolas, MS, is a Consultant at Biologics Quality & Regulatory Consultants, LLC (BQRC) specializing in regulatory and compliance issues related to Chemistry, Manufacturing, and Controls (CMC) microbiology. With extensive experience in mock inspections, gap analysis, and remediation, she provides expert advice on product quality microbiology and supplier audits. Her background includes over 250 reviews of regulatory drug and biologic applications submitted to the FDA.

Formerly an FDA investigator, Ms. Lolas has conducted pre-license and pre-approval inspections of therapeutic protein manufacturing facilities. Her deep understanding of cGMP, microbial control, and process control ensures that clients meet stringent regulatory standards and maintain high-quality production practices.

Call her at 240-421-5408