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In The Biomed Industry

“Eran Yona and Bio-Chem have many years of experience in the pharma industry, from the design stages, construction of production sites, and validation and manufacturing to GMP standard. In all our interactions with Bio-Chem, the objectives were met and I was very satisfied with their recommendations and practical suggestions. Eran assisted the companies I was involved with to overcome manufacturing and regulatory obstacles.”

“Following the completion of a 4 year mega-scale project to develop a new product, I had the opportunity to work with Eran and the Bio-Chem team on the design control file for the new product. Eran (owner of Bio-Chem Engineering) led us through the full process with very clear and coherent guidance. Eran and the team showed us the way through the mass of documentation collected throughout the whole project, from initiating the new product requirements, to the completion of the product validation, to the final delivery of the manufacturing line to the plant operation facilities. I warmly recommend Eran as a skilled professional in the field of compliance and regulatory documentation.”

“I enjoyed working with Eran and Bio-Chem. They performed excellent professional work, while keeping to the study plans defined at the start of the various projects, submitted the project deliverables on time, for a large number of manufacturing process engineering and validation projects.”

“Eran Yona and the Bio-Chem team are very experienced in giving consulting services in the areas of quality and validation to the pharma and medical device industries. In the last four years, I worked on several projects with the Bio-Chem team and Eran Yona. After having used the various services Bio-Chem offers, on several occasions, I can say with certainty that the Bio-Chem team are very professional while focusing on service-orientated consulting and addressing the challenges in the fields of quality and validation.”

“I’ve worked with Bio-Chem for the last three years on a biological manufacturing process scale-up; this tech transfer project included commissioning, installation and qualification of tailor made equipment, which was which was built to meet the unique needs of the manufacturing process, building of ISO6 level clean rooms, validation and qualification of clean rooms.

“Eran Yona performed quality and GMP audits as well as supplier and subcontractor ISO 13485 audits in the framework of a supplier qualification process our company performed. We received from Eran professional excellence, deep knowledge of cGMP and ISO, service orientation and a fast response to everything we needed. The audit documentation reports were provided to us within a short time period. Questions that we raised were answered quickly and with a high level of detail and precision. I would be happy to work with Eran Yona again in the future on any project that is needed.”

““We used Bio-Chem for a GMP inspection at one of our TEVA manufacturing sites. The auditor was professional and experienced. The GMP inspection was performed in a thorough and businesslike manner. Thank you very much!”

“I was happy to work with Eran and the Bio-Chem team. They are reliable and very professional in the pharma and medical fields. They provide all your validation requirements under one roof, which simplifies the regulatory process. With Eran’s many years of experience, I was impressed by his ability to advise you on almost all aspects of biotech, pharmaceuticals and medical devices.”

“Eran Yona and Bio-Chem led Tiltan Pharma in the area of production and validation for several years for several formulations over a number of years. They were very professional and instrumental in the preparation for production of clinical lots as well as in the actual production work in the clean rooms. Eran did it all with a smile, even after long (sometimes very long) hours of work and when facing non-trivial process challenges.”

“I am writing to recommend the services of Bio-Chem Ltd. Shai and team members have been working with Teva Medical for 3 years as our consultants. The professional knowledge, services and attention to detail of Bio-Chem helped keep our company on track during this challenging time. I feel confident in recommending Bio-Chem’s consulting services.”

“To the Bio-Chem team: Working with you was professional and businesslike, as well as engaging and pleasant. Thank you for your support throughout the period we worked together, and we are happy to recommend Bio-Chem as an excellent and professional consulting company.“

“Eran Yona and the Bio-Chem team consulted for Sigma-Aldrich on GMP and Validations for an FDA regulatory inspection. The company was professional and service-oriented throughout the entire project, and all the documentation supplied was well written and detailed, which allowed us to complete the project on time and successfully.”

"Bio-Chem led the planning of the clean rooms at a higher-than-usual standard, supervised building and testing, and the qualification and validation of the clean rooms, the system and equipment."