Clinical and Regulatory Consulting Services for the Medical Industry

iStock 000009534994XSmallThe purpose of the pre-clinical studies, which are an important step in the product development process, is to produce a comprehensive set of data regarding the safety and efficacy of the device or procedure. These tests should support the regulatory requirements as well as to provide a rationale basis for the clinical development plan selected for the product.

Dr. Chen-Zion combines her regulatory and scientific knowledge to prepare specialized pre-clinical programs which consider each product's unique properties. She designs pre-clinical plans which significantly strengthen and shorten the time to regulatory submissions (IDE, CTA, 510k etc.)

Pre-clinical services include:

  • Evaluation and assessment of pre-clinical programs
  • Design of pre-clinical studies (Bench tests, Biocompatibility, Animal models)
  • Evaluation and selection of laboratory organization(s)
  • Preparation of Study Protocols
  • Experimental project management and/or monitoring testing sites
  • Study and summary reports preparation
  • Preparation of pre-clinical sections of IDE, 510K, and PMA applications

Malca Chen-Zion, Ph.D.

malcaDr. Chen-Zion has over two decades of experience in the fields of regulatory affairs, preclinical research and clinical trials of medical devices and biotechnology. Dr. Chen-Zion holds a Ph.D. in Biology with highest distinction from Bar-Ilan University.

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Contact Details

793 Nachal Kisufim
      Makkabbim 7179901 Israel