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Eran Yona
Professional end to end consulting
for Bio-Pharma, Medical Device, and E-Health companies.
Part of the reasons to hire my Bio-Med consulting services:
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.
Your trustable partner
Using secured network solutions and committed to 100% confidentiality and secrecy of your valuable information and intellectual property.
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.
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.
Always remember the bottom-line
Business-oriented thinking and strategy considerations with pragmatic thinking will be implemented throughout the entire consulting phase.
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.
What kind of Bio-Med companies can benefit from my experience & professionalism?
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.
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.
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.
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.
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.
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.
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.
