Donna Schwartz, as Co-Founder and Regulatory Affairs Principal at Consulting on the Green, LLC, brings over twenty years of extensive experience in regulatory submissions across the United States and the rest of the world. Her profound scientific expertise encompasses nonclinical pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), and toxicology,...
Donna Schwartz, as Co-Founder and Regulatory Affairs Principal at Consulting on the Green, LLC, brings over twenty years of extensive experience in regulatory submissions across the United States and the rest of the world. Her profound scientific expertise encompasses nonclinical pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), and toxicology, making her an invaluable asset in navigating the complex regulatory landscape for vaccines, biologics, and small molecules. At Consulting on the Green, Donna is instrumental in guiding clients through the intricacies of regulatory affairs, ensuring compliance with FDA regulations and international standards such as the International Conference of Harmonization (ICH) guidelines.
Currently, Donna is spearheading key projects that involve the preparation and submission of electronic Common Technical Documents (eCTD), leveraging her in-depth knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards. Her expertise in authoring tools enhances the efficiency and accuracy of regulatory submissions, significantly reducing time to market for her clients’ innovative therapies.
In addition to her regulatory prowess, Donna's skills in clinical research, oncology, and clinical pharmacology position her as a thought leader in drug development. Her proficiency in developing Standard Operating Procedures (SOPs) and scientific writing further underscores her commitment to excellence in the regulatory domain. By fostering strong partnerships with her clients, Donna not only supports their immediate regulatory needs but also empowers them to navigate future challenges in the ever-evolving landscape of pharmaceutical development.
