Owner and principal consultant at Dr. Hagit Marchaim RA Consulting (HMC-regulation)
HMC-Regulation, Israel
Hagit Marchaim, PhD, MBA, is the owner and principal consultant at Dr. Hagit Marchaim RA and Drug Development Consulting, HMC-regulation. HMC-regulation works with companies at different size, from startups to global companies, and helps companies from very early development stages through IND, NDA and post approval submissions. With 19 years of experience in regulatory affairs, including several Dept. Head and VP roles in small as well as in global big pharma companies, in addition to consulting, Hagit played a key role in development and/or approval of many types of products, including biologics (antibodies, plasma products and toxins), small molecules and combination products. These included new molecular entities and 505(b)(2) submissions, in indications spanning CNS diseases, cancer therapies, ophthalmic, surgery products, urological treatments and more. Hagit is a regulatory affairs and drug development executive, with strong scientific, clinical and business strategy knowledge and over 20 years of experience in biotech, pharmaceutical and combination products companies (first in R&D and then in regulatory affairs), ranging from very early development stage, through clinical phases to marketing and post marketing stages.
HMC-regulation services include product development, including pre-clinical, clinical and GMP requirements, management of meeting and regulatory submissions to FDA, EMA and ROW Health Authorities, preparation of regulatory strategy, gap analyses and complete registration files.
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What are the Requirements for an IND Submission?
Monday, October 2, 2023
8:30 AM – 4:00 PM EDT