Clinical and Regulatory Consulting Services for the Medical Industry

due diligenceOne of the best ways to assess the viability of an investment in a biotechnology venture is to conduct a scientific and regulatory review of the project.

The conventional due diligence process evaluates a potential investment, merger or acquisition by focusing on the financial and business aspects of a company or project. Many investors fail to adequately investigate the science and technology associated with the enterprise.

Investors can reduce risk and avoid costly mistakes with professional assessment of a project's science and technology. Questions to be addressed include: Is the technology grounded in sound science? Is it practical and effective? Will this technology work? Is this really a unique and proprietary technology?

Scientific and regulatory due diligence can be helpful to investors, researchers, entrepreneurs, corporate investment and funding groups, venture capitalists, investment bankers, corporate merger and acquisition teams, agencies and companies evaluating internal R&D and technology development, as well as lawyers and other professionals who have disclosure obligations.

Dr. Chen-Zion's broad scientific background, in-depth knowledge of the regulatory framework, and extensive experience with all phases of product development enable her to identify and locate a company's assets as well as its weaknesses and limitations.

Dr. Chen-Zion provides professional scientific and qualitative regulatory due diligence services aimed at helping investors make more informed decisions secure investments.

Scientific and regulatory due diligence includes:

  • Review of business plans
  • Regulatory opinion regarding product development and strategy plan
  • Opinion regarding project selection
  • Assessment of research projects, covering all phases of product development including: pre-clinical, clinical and regulatory interactions
  • Customized services for venture capitalists

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