Tikun Olam CEO
Tikun Olam CEO
“Eran Yona from Bio-Chem assisted Kamada in Cross-Contamination Risk Assessment project. Eran lead a comprehended Risk Assessment in various departments in the plant and brought to our attention several unique GMP observations which led us to improvements implementation accordingly. The Risk Assessment was completed successfully and on time”
QA project manager, Kamada
“I know Eran Yona and Bio-Chem for the last 8 years. As Sigma-Aldrich new GMP plant Engineering manager, Bio-Chem supplied GMP and Validation consulting services towards FDA inspection.
Bio-Chem team is a very dedicated and committed to project tasks and challenges. Eran and his team used their vast experience in Engineering and Regulation areas in the bio-pharmaceutical industry and created a significant value to the company. Bio-Chem has created an effective working relationship with a variety functions in the company shortly and all goals were achieved on time and in a satisfactory manner. FDA inspection was a success. I am sure Bio-Chem will bring great added value to any organization that will use their services.”
GMP plant Engineering manager
“I have used Bio-Chem, for external GMP inspection in one of our TEVA facilities.
The inspection was done in a very professional manner by Bio-Chem team.
The inspector was well skilled and experienced; and the inspection was thorough and efficient.
Sr. Director GMP QA, Innovative R&D, Teva
“Bio-Chem escort our company for several years, mostly on GMP, Quality System inspections, Quality Control and Validations.
Project completed by Bio-Chem supported our base business regulatory requirements as well as for leading our company to cosmetics OTC products manufacturing and export to the US market.
Bio-Chem has proven high professional level, reliability and projects tasks completion in challenging time lines”
Quality inspection audits manager
“Many thanks for Eran Yona & Bio-Chem team.
You did an excellent job for our high complexity project, in a professional manner and to the point.
You considered our needs and constraints in patients, understanding and polite manners.
The validation folder you created for our both Maxima’s manufacturing sites were supererogatory, well organized, detailed and easy to use.
I will definitely recommend Bio-Chem excellence and professionalism”
Quality, Safety and Ecology Manager at Maxima Group
“Bio-Chem team and Eran Yona are well rounded in providing Quality and Validation services to the Pharma and Medical industries.
In the last four years, I have been working on several projects with Eran and Bio-Chem team.
Exposed to the services in these several occasions, I can be definitive that Bio-Chem team is highly professional and highly service orientated in delivering Quality and Validation assignments”
Cyber Security CEO at Tera-zone
“Phoenicia worked with Bio-Chem team on glass product quality improvement project. As part of the project, Bio-Chem team conducted a comprehensive research on the current manufacturing and storage processes through the entire supply chain in Pheonicia plant.
I warmly recommend Bio-Chem, especially their unique service standards, reliability and professionalism”
QA manager at Phoenicia
“Eran Yona performed two GMP and one ISO audits that evaluate our contractors. Excellent performance, deep cGMP/ISO knowledge, customer orientation and fasts communication characteristic. Final audit reports were provided during a really short time, and additional questions that I had were answered quickly and accurately. It would be a pleasure to work with Eran on any project again in the future”
QP at Zoetis
“Eran and Bio-Chem’s team is great to work with. They are reliable and very knowledgeable in their field. They provide all your validation requirements under one roof, which simplifies the regulatory process. Eran’s have years of experience and has the ability to advise you on almost all the aspects of Pharma, Biotechnology and Medical Device”
QA/RA at AB Dental
“Eran Yona and Bio-Chem performed a large scale Operational Excellence and Efficiency Improvement project at our pharmaceutical compounding facility. The project included several critical complex operation procedures mapping which are being performed mostly in clean rooms. The project was completed in a very professional manner that demonstrated deep knowledge of Bio-Chem in the Operational Excellence area. The recommendation given by Eran from Bio-Chem, were very practical and helpful to our efficiency improvement process that was implemented. I warmly recommend Eran Yona and Bio-Chem services”
Medical risk compliance Neopharm
“Eran Yona and Bio-Chem has many years of experience in industrial pharmaceuticals from design to construction, validation and GMP manufacturing. In all our interactions I was very satisfied with their recommendations and practical suggestions. They helped the companies I was involved with to overcome practical manufacturing and regulatory obstacles”
CEO at Medicortex Finland Oy
“Bio-Chem led Tiltan Pharma production for several years and various formulations.They were very professional and instrumental in the preparation for production as well as in the actual production work. Eran was doing all that with a smile, even after long (sometimes very long) hours of work and facing non-trivial challenges”
Clinical Research Director at MSD
“I enjoyed working with Eran and Bio-Chem. They performed excellent professional work with defined and well-written study plans, delivering on time the required services in several pharmaceutical manufacturing and validation projects”
Chief Scientific Officer at Space Pharma SA
“Bio-Chem has supported Neopharm group mostly in process engineering, validation, GMP and quality issues in the bio-pahrmaceutical fields as well as Medical Devices.
Bio-Chem has also participated clinical batch manufacturing including aseptic production and media fill simulations.
Bio-Chem team are very experienced, qualified, reliable and talented consultants”
Operation manager Instrumetrics
“Eran and Bio-Chem’s team were instrumental in assisting my group to complete qualification activities prior to, during and after key audits by regulatory bodies. His team was engaged mostly in cleaning validation, equipment validations and various utility validations. The team’s input allowed us to make the progress needed and meet the quality levels expected by the various regulatory bodies during particularly difficult times”
process Technology specialist at Omrix
“I am working with Bio-Chem for the last three years on a scale-up and tech transfer and validation of manufacturing process of 2 sterile biologic products. This project contains complex customized equipment, ISO 6 clean room construction and qualification, process development, Control and Automation and etc. Eran and his team were deeply involved on the commissioning of clean utilities, clean room HVAC system, process equipment, computerized system validation, software validation, control and automation systems verification and validation and quality assurance services. Eran served both as mentor to his team (training, guiding, directing, knowledge, solving problems and etc.) and also supported directly different critical activities were hands-on complicated and time constrain activities were required. Bio-Chem provide high quality performance and documentation with complete accountability to time and budget”
Project Manager at Omrix, a Johnson & Johnson company
“Eran from Bio-Chem supported and Counseled Medimor Ltd. during transformation from antenna Manufacturer company named “Galtronics” to be a one of the leading Medical Device turnkey subcontractor in Israel. The project included state of the art clean rooms facility design and inspection, qualifications and GMP training.
I enjoyed working with Eran and Bio-Chem team. They performed excellent professional work and were very committed to the project with the highest standards a customer can ask for.
Eran and Bio-Chem Completed the project tasks in satisfactory quality level and in a timely manner”
Quality Engineering manager at J&J
“Following the completion of a 4 year mega-scale project, developing a new product, I had the opportunity to work with Eran&Bio-Chem’s team on the Design-Control file for the new product. Eran (Owner at Bio-Chem Engineering) led us trough the full process with a very clear and coherent guidance. Showing us the path within a mass of numerous documentations collected during the full process from initiating the new product requirements, up to the completion of the validation of the product, at the end of the delivery of the manufacturing-line to the plant operation facilities. I highly recommend Eran as a skilled professional in the field of compliance and regulatory documentation”
R&D Manager at Albaad-Fem