Eran Yona – Founder of Bio-Chem
Bio-Chem Ltd was established by Eran Yona in 2007. It is a boutique company offering high-standard consulting, with maximum flexibility and real value creation. Eran Yona founded the company with a passion for the fields of medicine and sciences, a passion he has deeply-held since biology class in high school. Eran has worked in the fields of research and development, manufacture and management. It is through his extensive experience that he understands that meeting high standards and breaking regulatory barriers is a Bio-Med company’s entry ticket into international markets. Based on the many years of experience and reputation accumulated in Israel and around the world, at Bio-Chem, we offer to consult at the highest levels. You are, as our customer, guaranteed to get the expected results. We work according to a standard project management methodology, perform a risk identification and analysis process, and survey gaps to maximize your chances of success. In each project we define measurable parameters to enable effective monitoring and follow-up after each stage. At Bio-Chem we anticipate and forecast the direction of developments in the fields of health, pharmaceuticals and medicine and we are well aware of all the changes, transformations and innovations that will be an integral part of the medical world of the future. Like the rest of the fields, the biomedical sector is also undergoing a rapid change. Therefore, it is important to understand this change in order to be part of the promising and exciting future of this industry and in order to generate future value accordingly.
Our consulting services
Research and development
Consultancy in a variety of areas including design, research labs and clean rooms, development technologies, investor business presentations, regulatory strategy, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC, professional training.
Design and engineering
Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation with a combination of theoretical knowledge, practical experience, and in-depth understanding of the biometrics regulation and principles and in accordance with the GxP principles.
Manufacture and packaging
Consultancy in manufacturing plant design, development and engineering of manufacturing processes, selecting the most appropriate technology, process gable, technology transfer, GMP, process improvement, utilization optimization and improvement, employee training and equipment validation, systems, production processes and cleaning.
GXP, Quality Validation
Advises, establishes, accompanies and upgrades systems of various types of quality management, executes GMP trainings and courses, assimilates the company’s GxP principles, ISO 13485, assures quality and prepares for global regulatory audits while conducting risk analysis and evaluation, equipment, systems, software, testing methods, manufacturing processes. And cleanliness until successfully audited.
Regulation and registration
Regulatory consulting and drug registration, EMC, CE Mark, nutritional and cosmetic supplements in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and requirements in a professional manner, in a short time, outlining the product, shelf life and graphics, import certifications and meetings with regulatory bodies and up to approval .
Software and systems
Digital healthcare consulting, software development and medical applications in accordance with 21CFR part 11 / Annex 11 / HIPAA / GDPR requirements, ISO 13485/27001/27799, CE marking, Risk Assessment, and software validation and control systems up to marketing approval.
Articles we wrote for your use
Cosmetics product registration and submission in Israel
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and [...]
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Risk Assessment and Risk Management in the Medical and Pharmaceutical IndustriesRisk Assessment and Risk Management in the Medical and Pharmaceutical Industries
Articles, Medical Device, Medical Device, Phama/BioTech, Phama/BioTech articles, איכות ו-GxP, אמ”ר, ולידציה והסמכות, מצוינות תפעולית, פארמה וביוטק
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, [...]
Fermentation in the biopharmaceutical industry
1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular [...]