“The and Bio-Chem team and Eran Yona executed a large operational excellence and efficiency improvement project at our pharmaceutical manufacturing and compounding facility.
The project included review and mapping of several critical, complex operational processes, most of which are performed in clean rooms.
The project was completed in the most professional manner by Bio-Chem, and demonstrated vast knowledge in the area of operational excellence and efficiency. The recommendations given by Bio-Chem were practical and greatly helped us to implement the efficiency process. I very warmly recommend Eran Yona and the services of Bio-Chem.”
QA Manager, Phoenicia
Phoenicia Glass Works Yeruham worked with Bio-Chem on a project to improve quality processes for glass products supplied to company customers. In this framework, Bio-Chem conducted comprehensive investigation of the manufacturing and storage processes throughout the supply chain at the plant. I warmly recommend Bio-Chem, especially their unique standards of service, reliability and professionalism.”
“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.”
“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.”
Dr. Moshe White
QA Project Manager, Kamada
“Eran Yona of Bio-Chem assisted Kamada with a cross-contamination risk assessment project. Eran led a comprehensive risk assessment in different departments at the plant, brought some special problems to our attention, and followed up to implement several GMP issue improvements. The entire assessment was very successfully completed within the defined timelines.”
Quality, Safety and Ecology Manager, Maxima Group
“Many thanks to Eran Yona and the Bio-Chem team. You did complex work in a precise and professional manner, while considering our needs and constraints with patience, understanding and courtesy. The validation folders you prepared for two Maxima manufacturing sites were organized, clear and easy to use, beyond our expectations. I am happy to recommend Bio-Chem as an excellent and professional company.”
“I met Eran Yona and Bio-Chem 8 years ago when I was the GMP plant engineer at Sigma-Aldrich. Bio-Chem supplied GMP and validation consulting in preparation for an FDA inspection.
Eran’s and the team’s work demonstrated their professionalism and commitment to the success of the audit, an they succeeded in achieving fruitful cooperation in the company in order to efficiently perform the required work during a relatively short time. I have not doubt that many pharma and medical companies can gain value from Bio-Chem’s many services.”
Quality Inspection Audits Manager
“Bio-Chem consulted for our company for several years on GMP issues, quality audits, QC and validation. The projects run by Bio-Chem supported our routine activities, while meeting regulatory targets and also led us to qualify the facility for manufacturing and export of cosmetic products to the US market. Bio-Chem has proven to be highly professional and reliable, and met the challenging timelines.”
“Bio-Chem accompanied and consulted for Tikum Olam in the fields of medical cannabis growth and product manufacture, quality, validation, training, regulation and purchasing of manufacturing equipment, GAP, GMP, planning and establishing a new GMP facility. Eran and the team did excellent work. We fantastic job. They received excellent service from the professional side and broad knowledge at a high standard. I warmly recommend Eran Yona and the Bio-Chem team for medical grade cannabis consulting.”
““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!”
“Eran Yona and the Bio-Chem supported the Neopharm group in challenging projects in the fields of manufacturing process engineering, validation, GMP and quality in the fields of pharma, medical devices and biotech. Eran Yona and his team also led in manufacturing of GMP batches for clinical trials, including manufacturing of aseptic products and media fill batches.
Eran and the Bio-Chem team are very professional, experienced, talented and reliable.”
“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 and the Bi-Chem team were deeply involved in the project, particularly during engineering testing and qualification stages (commissioning), equipment validation for critical systems, and in the verification and validation processes. Eran acted as both a consultant to teh Bio-Chem team during the project (mainly for training, direction, professional knowledge deviation investigations, problem-solving, etc.) and he also directly gave support in a number of project critical activities which Bio-Chem provided in the framework of the project. They performed at a high level, and provided documentation in compliance with requirements for the system ad the manufacturing processes of two types of sterile bio-pharmaceutical products, manufacturing processes, control systems, automation and more, for the critical control and automation programs and systems of the project. It required active intervention and keeping to challenging and tight timeline, and in compliance with the regulations, done responsibly and within the limits of the schedule and budget.”
“Eran from Bio-Chem supported and counseled Medimor Ltd. during its transformation from an antenna manufacturing company named “Galtronics” to one of the leading subcontractors in Israel for planning, development and production of medical equipment and medical devices. 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. The project included GMP training and for employees who did not originally have any background it the biomed field. I enjoyed working with Eran and the Bio-Chem team. They performed excellent, professional work and demonstrated high levels of commitment throughout the project, while keeping to the highest standards and accommodating the customer’s requests and meeting their expectations. Eran and Bio-Chem completed the project tasks at the required level of quality, while keeping to challenging and tight deadlines, with responsibility and within time and budget constraints.”
Process Technology Specialist, Omrix
“Eran and Bio-Chem’s team were instrumental in assisting the group I manage to complete qualification activities prior to, during and after important audits by regulatory bodies. The Bio-Chem team was engaged mostly in cleaning processes validation, equipment validations and various utility validations, in order to achieve the desired progress and to improve the levels of quality we requested.”
“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.”
“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 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, teh 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.”
QA Manager, Phibro
“Many thanks to Eran Yona and the Bio-Chem staff. The company was invited on short notice to our new facility to support an FDA inspection. The job was done professionally while meeting very tight and rigid deadlines. We worked with a professional team with lots of patience and courtesy. I am happy to recommend Bio-Chem as an excellent and professional consulting company.”
“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 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.”
“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.”
“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 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.”