Ms. Rivka Zaibel

I have 30 years of experience in the biopharmaceutics and biotechnology industry. This includes 19 years of experience in regulatory and quality management of drugs, biologics, devices and combination products development. I 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 me is concurrently providing regulatory and quality support to approximately 15 startup companies in Israel, India, China, US and Brazil, focusing mainly on recombinant proteins, cell therapy, cell based implantable products, medical devices, peptides, vaccines and combination products.

I 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. I provide 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 and NDAs to the FDA and EMA (recombinant proteins, vaccines) and 2-PMAs for hyaluronic acid based medical devices, which lead to the approval of two recombinant DNA proteins, one recombinant HBsAg vaccine and three medical devices. Registration of one recombinant DNA protein and on recombinant HBsAg vaccine in Israel. Leading numerous inspections of the FDA, EMA and Israeli MOH. Establishment and maintenance of quality systems for multiproduct biotech facilities to comply with FDA, EMA, ISO 9001 and ISO 13485.

In 2020 Ms. Zaibel was appointed Mentor in the Weizmann Institute of Science SPARK project.