Rivka Zaibel

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Rivka Zaibel is the Founder, Owner and President of ADRES, Advanced Regulatory Serivces, RIvka has more 35 years of experience in the biopharmaceutics and biotechnology industry. This includes 19 years of industry experience in regulatory and quality management of drugs, biologics, devices and combination products development. Rivka gained significant experience in leading and managing multidisciplinary projects, and coordinating internal as well as external activities from lead compound identification to CMC, preclinical and clinical development through product registration.
The Company founded and headed by Rivka is concurrently providing regulatory and quality support to approximately 25 startup companies in Israel, India, China, US Europe and Brazil, focusing mainly on recombinant proteins, cell therapy, cell based implantable products, medical devices, peptides, vaccines and combination products.
Rivka constantly keep up-to-date with the regulation, both in the US and in Europe, regarding the development of all of those products, and have attended numerous meetings with regulators to discuss development projects for such products. Rivka provides training lectures in the area of Regulatory and Quality considerations in the development of biopharmaceuticals and established quality improvement plans for global pharmaceutical companies.
Major accomplishments include the successful compilation, coordination and submissions of several pre-IND briefing packages, INDs, NDAs BLA, PMAs and MAA to the FDA and EMA (recombinant proteins, vaccines). Leading numerous inspections of the FDA, EMA and Israeli MOH.
In 2019-2020 Ms. Zaibel joined the Weizmann Institute of Science SPARK project as a mentor and is also a member of the advisory board for a new Master degree in Regulatory and drug development in TAU.
In 2022 the ADRES team lead by Ms. Zaibel joined BIODESIGN ISRAEL Rambam healthcare campus program as mentors.

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