Dr. Hagit Marchaim

Online course on IND requirements

Dr. Hagit Marchaim

Regulatory Affairs and Drug Development Consulting

Regulatory Services

Regulatory strategy

Regulatory assessment

Regulatory Affairs training

Preparation and review of CMC, pre-clinical and clinical documents

Management of meetings with Health Authorities

Speaking at the RAPS EU Convergence 2025

Served as a speaker in two sessions at the RAPS Convergence in Brussels, participating alongside representatives from the FDA, EMA, and FAMHP. The sessions provided a valuable forum for in-depth discussion on regulatory innovation with global health authorities and industry experts.

RAPS Convergence 2024

I had the pleasure of speaking once again at the RAPS Convergence in September 2024, held in Long Beach, California. This time, I focused on maximizing the potential of meetings with the FDA, utilizing the solution circle format to facilitate engaging discussions with the audience.

RAPS ISRAEL LNG 2024 Lecture

Israel LNG Virtual Event: Navigating Recent Regulatory Aids Virtual Event: From FDA Guidelines to AI Solutions for Biopharmaceuticals, Medical Devices, and Combination Products | RAPS

Three lectures on regulatory updates and technology: FDA’s AI Regulation in Product Development, GenAI in Reg. Intelligence, and Recent FDA guidelines on Bio/Pharma and Combination Products.

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Workshop on IND request the RAPS convergence, 2023

I was excited to lead the workshop on IND requirements at the RAPS (Regulatory Affairs Professionals) Convergence in Montreal. Together with Dr. Tyler C. Vandivort and Ms. Lina Jamis,  we navigated the CMC, non-clinical and clinical requirements for IND submissions, as well as the strategy for a successful pre-IND meeting. The RAPS Convergence is one of the largest regulatory conferences, with thousands of participants from all over the world, including many lectures from representatives of FDA, EMA, Health Canada and other Health Authorities. I highly recommend this annual event for RA professionals.

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Dr. Hagit Marchaim

Dr. Hagit Hoch-Marchaim has 24 years of experience in the Biotech industry, 20 years of which in Regulatory Affairs positions (her other roles were in R&D and pre-clinical development). Hagit has gained significant knowledge and experience in all aspects of drug development throughout the product life cycle. She started her career in Regulatory Affairs at Makhteshim – Agan Industries, and continued at Kamada Ltd. as an RA product manager and pre-clinical development manager, at Omrix Biopharmaceuticals Ltd. (a J&J company) as the RA Dept. Head, and at CureTech Ltd., Alcobra Ltd. and then at Intec Pharma as the VP RA.

Hagit has started her business of regulatory affairs and drug development consulting (HMC-regulation) in 2012 and since then has worked with both start-up’s and global companies on various product types and indications, including plasma products, biologics produced from cell culture or bacteria, gene therapy products, combination products, drugs (both new molecular entities and 505(b)2 products) and cannabis based products. In addition, she has gained some experience with a cultivated meat product.

Hagit holds a Ph.D. in Biology from the Hebrew University of Jerusalem and completed her post-doctoral studies in the Weizmann Institute of Science. Hagit holds also an MBA degree (Biomedical Management, summa cum laude) from The College of Management, Israel.

At Omrix Biopharmaceuticals Ltd. Hagit served as the RA Department Head, where she managed 13 RA employees and was responsible for many successful regulatory submissions (both pre- and post- marketing authorization) worldwide (including FDA, EMA, IMOH, Canada, Asia Pacific and Latin America). Hagit attended many regulatory meetings, with the FDA, IMOH, EMA, PEI and Health Canada. In addition, she participated in FDA and IMOH plant inspections and was involved in other QA related activities including being a member in the Quality System Improvement Plan team organized by Ethicon, J&J. At CureTech Ltd., Alcobra Ltd., and Intec Pharma, her responsibilities as VP RA included preparation and management of FDA as well as EU, IMOH and ROW submissions, review of clinical documents, management of FDA meetings and advising on compliance issues.

Currently, Hagit shares her experience with companies as an independent consultant providing regulatory consultation services to companies, bio-med incubators and VCs, either on a permanent basis leading the Company’s Regulatory Affairs activities or on specific projects. Her consultation spans the whole spectrum of regulatory strategy, GAP analysis, regulatory submissions, preparation and management of meetings with Health Authorities, quality agreements, non-clinical and clinical studies, inputs on GMP manufacturing process for biologics and other CMC-regulatory work, data and marketing exclusivity and many more.

Hagit is specialized in biological products, drugs and combination products.