Iris Meiri-Bendek | Regulatory Consulting               
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For more than ten years I have managed and lead processes involving international regulations, quality assurance and product development in the field of food and dietary supplements.

During the last few years I served as Regulatory Affairs Manager for Enzymotec, a global biotech company, where I specialized in leading regulatory processes from idea to successful pre-marketing approval and gained extensive knowledge and valuable experience.

As the Regulatory Affairs Manager I was also responsible for providing full in-process and post-marketing regulatory support to the company's divisions and customers.

My experience includes leading processes such as preparation and submission of GRAS and NDI notifications, Novel Food applications, health claim submissions as well as other types of pre-market applications in Europe, USA, Australia, China, Japan, India, Korea and Israel.

I hold a Master of Science degree in Biotechnology (Cum Laude) and a Bachelor of Science degree in Food Engineering & Biotechnology, both from the Technion Institute in Israel.

Services

  • Determination of the products regulatory status.

  • Identifying the relevant regulatory tracks in the targeted states.

  • Setting strategy to obtaining pre-market approval or freedom to operate.

  • Management, preparation and submission of regulatory files (GRAS, NDI, Novel Food and others).

  • Defining and approving claims associated with the product.

  • Providing regulatory insights during product development.
     

Contact details

E-mail irisbendek@gmail.com

Tel: 972-54-5315999