Ms. Aimee Cousoulis is the founder and president of the independent consulting company GxP Pinch Hitting, LLC since 2009. Her experience in pharmaceutical product development and commercialization comprises varied and diverse business platforms including start-ups, universities, mid-sized and Fortune 500 companies.
Ms. Cousoulis’ and GxP Pinch Hitting partner with FDA regulated pharmaceutical organizations to provide technical, project management and compliance leadership and support for projects in early R&D, preclinical, clinical, and commercial phases. Projects types include NDA/ANDA project management for small volume parenteral, topicals and drug substances; quality assurance advisement for toxicology studies; sterile and solid oral dosage facility and supplier audits; quality system and procedure development; Warning Letter remediation, and process analysis of distribution systems. Experience in dosage form development includes lyophilized, intranasal, transdermal, and sublingual delivery systems.
Before founding GxP Pinch Hitting, Ms. Cousoulis held positions in operations and manufacturing, quality assurance, and business development with several large and small pharmaceutical companies. She holds B.A. degrees in Biology and English from the North Central College, a Master’s of Science in Biology from the State University of New York at Brockport and a graduate certificate in Validation and Regulatory Affairs from Stevens Institute of Technology. Ms. Cousoulis is also a certified Project Management Professional (PMP) and professional educator and trainer. She can be reached at email@example.com.
GxP Pinch Hitting, LLC
Founder and President