Lourdes Ramos, MT

GxP Compliance Consultant

Lourdes Ramos, BS MT has over 25 years overall experience in the regulated healthcare industry covering clinical (GCP), environmental, and pharmaceutical (GMP) areas. She has served as Sr. Clinical Administrator of the Department of Medicine at the University of Miami Miller School of Medicine. There she streamlined operations and maximized overall productivity. During her tenure at the Miller School of Medicine she was instrumental in the creation of the Interdisciplinary Stem Cell Institute (ISCI), a startup clinical research unit dedicated to cardiovascular application of stem cell therapies.

Lourdes is a certified GCP Auditor and has worked on the product development of antimicrobial formulations, specifically supporting the development of the clinical and non-clinical testing protocols for Phase 1 human studies. 

In the GMP area, she has served as a compliance consultant to consent decree pharmaceutical manufacturing operations focusing on environmental controls and environmental monitoring programs.  Lourdes supports early-stage companies’ efforts to navigate phase appropriate GMPs through Phase 2 studies and consults in large molecules and biologics through the development and creation of validation master plans, validation protocols and reports, environmental assessments, and environmental control programs. As part of supporting CMC teams, she also manages CMOs supplying upstream and downstream processes for the manufacture of clinical supplies for early phase studies.