Amy Summers, PharmD, BCSCP, FAPC, Consultant

Consultant at Restore Health Consulting

Speaker

Amy Summers, PharmD, BCSCP is a nationally recognized authority in pharmacy compounding and 503B outsourcing operations. She advises 503A pharmacies, FDA-registered 503B facilities, and GMP-regulated life-science organizations on building compliant, scalable, inspection-ready operations in an increasingly complex regulatory environment. Maintaining an active national portfolio across dozens of engagements each month, she supports start-ups, expansions, regulatory remediation, and enterprise-level operational transformation. A former Pharmacist-in-Charge, Director of Operations, and Managing Director of a 503B outsourcing facility, Dr. Summers brings executive-level insight into USP compliance, FDA inspection readiness, quality systems design, and risk mitigation. She works with privately held companies, PE-backed platforms, publicly traded organizations, hospitals, universities, and life-science innovators seeking strategic, leadership-level guidance.