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What Our Clients Say

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"Orna and her team are our first-in-line for any FDA submission activity, as well as professional services for clinical regulatory documentation."

Yehudit Kraizer, Director Regulatory Affairs 

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"I would say Orna & the team are the best choice for a startup because of their ability to simultaneously lead the process with extraordinary expertise while having the flexibility to adapt to the ever-changing needs of a startup."

Avner Halperin, CEO

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"Very dedicated, experienced team, open to new regulatory approaches. Closed the regulatory strategy for our product and we successfully achieved clearance in the US."

Ophir Lotan, VP RA

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"What astonished me most was the extent of involvement by orna & her group, they acted as if it was their own product".

Amir Gross, CEO

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"Extremely professional team with out of the box thinking."

Gera Stommer, CEO

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"Highly involved in the project. whats unique about Orna is that she tells you what you need to hear instead of what you want to hear, leading to a fast and more cost-effective process."

Omer Zelka, Founder & CEO

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"We referred to Orna & the group after receiving great recommendations. Their high level of expertise stood out since our first meeting throughout the whole process."

Omer Deutsch, CEO


"Complete transparency. Honest & expert feedback."

Sholmzion Shen, Co-Founder & CEO

“Orna & the biomedical strategy group take the time to become part of your company’ DNA. Their in-depth knowledge about our product and its competitive landscape were crucial for the process to succeed. Their clinical evaluation report was excellent, and we received the CE approval. "

Livnat Ben-Zur, General Manager & VP Business Development