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Repeat Solutions Circle
Repeat Solutions Circle

Hagit Marchaim, PhD, MBA

Owner and principal consultant
HMC-regulation, Israel

Hagit is a seasoned regulatory affairs and drug development executive with over 20 years of experience across the biotech, pharmaceutical, and combination product industries. With a strong scientific background, she brings expertise spanning the full spectrum of drug development - from early research through post-marketing approval.

She has deep experience in nonclinical and clinical development, GMP compliance, and regulatory interactions, including leading meetings with the FDA, EMA, and other global Health Authorities. Her skills include developing innovative regulatory and drug development strategies, conducting gap analyses, and compiling complete registration dossiers.

As an independent consultant, Hagit partners with companies, bio-med incubators, and venture capital firms to provide tailored regulatory solutions. She supports organizations both as a long-term regulatory lead and on targeted projects, helping to bridge science, regulation, and innovation.

Presentation(s):