Eran Yona

Consultancy services to lift your start up

Professional end to end consulting
for Bio-Pharma, Medical Device, and E-Health companies.

Why choose me?

Part of the reasons to hire my Bio-Med consulting services:

Experience

Guaranteed value

More than 20 years and 1,000 projects in a variety Bio-Med innovative technologies that led many loyal & returning clients from R&D to commercialization.

Confidentiality

Your trustable partner

Using secured network solutions and committed to 100% confidentiality and secrecy of your valuable information and intellectual property.

Documents templates

Access to my internal working tools

You can use my SOPs, protocols, and reports templates that will enable you to document things easily with full regulatory compliance.

Global network

Connect with the right people

Access to my personal global professional’s network- Clients, colleagues, and investors I know for 20 years that you can cooperate with.

Business orientation

Always remember the bottom-line

Business-oriented thinking and strategy considerations with pragmatic thinking will be implemented throughout the entire consulting phase.

Extra value

See the whole picture brighter

In addition to my conventional professional skills- I will support your Engineering, Quality and Regulation needs to make you see the big picture clearer.

3 industries I offer consulting services for.

What kind of Bio-Med companies can benefit from my experience & professionalism?

Medical Device

Syringes, pumps, injectables
Sensors, electronics
Patient care
Wound healing
Face mask, disinfectants
Combination products
Surgical implants
Surgical instruments
Diagnostics, monitoring

Pharmaceutical

Small molecules
Biologicals
Gene & Cell therapy
Nano-robotics
Biological sensors & diagnostics
Regenerative Medicine
Optogenetic
Preventive medicine
Personalized & Precised medicine

Digital Health

Software as Medical Device
Software in Medical Device
Telecare
Diagnostics
Telemedicine
Mobile health
Health analytics
Telesurgery
Digitized health systems

What are my consulting services composed of?

These are the consulting services I offer my clients:

Product Development

“Let your Ingenuity the chance to save humanity”

Choosing the most appropriate technology for all the Bio-Med industries is essential and you need to examine its advantages, complexity, and overall cost.

I’m personally committed to your product development all together with innovative technologies that will be based on the quality by design approach and the clinical, commercial, and business challenges and will lead your company to be a dominant player in the industry.

Auditor

“An outside objective and fresh view”

DD or regulatory body inspections are a significant milestone. Moreover, you will need to audit your suppliers, contractors, and business partners.

To ensure you choose the best partners along the way to meet the regulatory requirements, you need auditing capabilities, and proper guidance.

I’m a certified lead auditor, recognized and accredited by the global NSF, IRCA, and CQI, with a proven track record of many first and second-party audits worldwide.

Lab & Facilities design

“Reverse thinking – imagine how it will be operated and design it accordingly”

The laboratory or your manufacturing facility’s conceptual design must be integrated with the GxP principles. It has to be appropriately designed to support a safe environment for development, clinical, and commercial stages activities.

A well-designed facility will meet the GMP/GLP standards and enable a safe and high-quality product for human use and robust laboratory testing.

Quality, GxP & regulation

“Do it right”

The Bio-Med industry is considered very risky and regulated. The day-to-day activity must be based on good practices, documentation, and control.

The GxP and quality system implementation dominate all processes involved from product development through production, quality control, distribution, and post-marketing.

I will build a branded template document to your specific needs that will include all relevant sections and information to be used as part of procedures, policies, SOPs, and protocols writing.

Risk Assessment

“All is well until something happens, and it is too late already”

Our industry is considered a risky one.

The term “Risk-Based approach” is mentioned frequently in the FDA and Eu. Regulatory guidelines for pharmaceutical and medical devices.

Risk should be managed and controlled, whether it is being performed to comply with the regulatory requirements or as a business tool.

I will establish your Risk Management procedure and templates and help you identify, analyze, assess, and control the risk using smart mitigations activities.

Lecturer & mentoring

“Knowledge is power…but experience is everything”

Knowledge and understanding are critical in the Bio-Med industry. We are dealing with human lives, and as a result, we must do things right. Your staff must understand what they do, how they do it, and why.

I love to share my broad knowledge with my customers as part of the consulting phase. I have 20 different courses given to Bio-Med industry personnel with thousands of participants in various relevant topics.

Strategy consulting

“It does not matter if you go, it is more important that you go in the right way”

Bio-Med companies business strategy is unlike other industries. It has to be performed by someone who knows this industry, and it’s limitations.

I will support your high-level decisions making including the development of strategy and the execution of strategic plans to deliver the best results and position your product in the market.

Hello, I’m Eran –

A Tel Aviv-based Bio-Pharma and Medical Industry Expert.

With 20 years’ wide-ranging experience leading 1,000+ global pharma and medical device projects, my areas of expertise range from product development, manufacturing technology, new facility design, and establishing quality management systems to GxP assimilation, audits, validation, and final regulatory approval.

What value my clients receive?

I hired Eran’s consultant services for several projects while working as QA manager in the pharmacy services at Sheba Medical Center in robotics, software and clean rooms validation.
Each of the projects was professionally and cooperatively managed all through the project. The inputs and the knowledge that we have earned while working with Biochem improved performances and promoted us towards regulatory approvals.

Shirly Rosenstadt-NevoQA Supervisor at Curetech
Eran Yona has many years of experience in industrial pharmaceuticals from design to GMP manufacturing.
I was very satisfied with his recommendations and practical suggestions.

Dr. Adrian HarelCEO – Medicortex
I found Eran to be professional in my interactions with him and responsive to my inquiries.
I would definitely partner with Eran again and I highly recommend his services.

Lars NageraSenior Manager – Giliad
Eran served both as a mentor and also supported directly different critical activities.
Eran provided high-quality performance and documentation with complete accountability to time and budget.

Yaki SidisGeneral Manager – Omrix (J&J company)
Eran served both as a mentor and also supported directly different critical activities.
Eran provided high-quality performance and documentation with complete accountability to time and budget.

Yaki SidisGeneral Manager – Omrix (J&J company)
Eran, thank you for the quality of service provided. We sincerely appreciate your efficient, gracious customer service, the level of detail and accountability.

Shiri MenachemiExecutive operations manager – Emedgene
We meet many people throughout our careers, but only some leave the marks, and one of them is Eran.
I would recommend contacting Eran and being sure this is the right choice.

Ofer AlexanderManaging director – Medimor medical
Eran was very professional and instrumental and was doing all that with a smile, even after long (sometimes very long) work hours and facing non-trivial challenges.

Dr. Dan GoldstaubManaging director – MSD
I enjoyed working with Eran.
He performed excellent professional work with defined and well-written study plans, delivering the required services in several pharmaceutical development projects on time.
Dr. Shimon AmsalemChief Scientist & Technology – ADAMA
Eran Yona supported me throughout the entire project. He was task-oriented and committed to project timelines, pleasant to work with, and very professional.
I can warmly recommend Eran Yona for global industry consultancy.

Yaron HaitovichProjects manager
Eran Yona was professional and service-oriented throughout the entire project.
He supported us to complete the project on time and successfully.

Inbal KapryEngineering & QA manager – Merck
II would greatly like to recommend Eran Yona.
He was very dedicated, very professional, work very quickly and was also very pleasant to work with.

Dr. Roni AttaliSenior director – Aidoc medical
Eran was very professional, well-skilled, and experienced, and the inspection was thorough and efficient. Thank you!

Dr. Gali GuzikevichSenior Director R&D Lab Manager – Teva
Eran is great to work with.
He is reliable and very knowledgeable in almost all the aspects of pharma, biotechnology and medical device.

Stephen ShattensteinQA manager
Many thanks to Eran Yona.
The job was completed professionally although the very tight timelines. Eran was very pleasant and kind.
I would be happy to recommend Eran’s consulting services.

Simcha VasanaQA manager – Phibro
Thank you Eran.
Working with you was very professional and efficient. You were pleasant and kind throughout the entire project.
I Thank you for your support and will be happy to recommend you for your excellence and professional consulting service.
Dr. Yael KoreshQA manager – Minipack
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