What Our Clients Say

"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

"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

"Complete transparency. Honest & expert feedback."

Sholmzion Shen, Co-Founder & CEO

"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

"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

“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

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

Gera Stommer, CEO

"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

"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."