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Hagit Hoch-Marchaim

Dr. Hagit Marchaim
RA consultant

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Bio-pharma sector

About My Business:


Regulatory Affairs and drug development executive, with a strong scientific, clinical and business strategy knowledge and 16 years of experience in biotech, pharmaceutical and combination products companies, ranging from very early development, through clinical phases (including clinical trial design, discussions with KOLs, preparation of clinical documents and regulatory submissions for clinical trials), to marketing and post marketing stages. Experienced in product development, pre-clinical and clinical trials and design, GMP requirements, meeting and submissions to FDA, EMA and ROW Health Authorities, preparation of regulatory strategy and gap analyses as well as complete registration files. Experienced in a broad range of products, including different cancer therapies, antibodies, products used during surgery, therapies for CNS impairments, implants and others. Consulting to companies from early R&D stages to post-marketing approval.

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