Bio-Chem Ltd. (2007) provides consulting services on product development, technology, facility design, regulation and registration, quality, GxP and manufacturing to biopharma, medical device, digital health, and dietary supplement companies.
Bio-Chem offers a range of professional services, courses, training and advice at the highest professional levels, with a the focus on the customer and emphasis on quality and regulatory requirements, all while embracing innovation alongside efficiency to maximize value for our customers.
We make every effort to:
- Meet customer expectations
- Meet all technological, engineering, and regulatory challenges and milestones
- Ensure collaboration and guidance, professional service, personal approach, flexibility, and timeliness
Our Mission
Our mission is to accompany, advise and assist biopharma, medical device, digital health and dietary supplement companies at all stages, and to meet the development, planning, operation and technology challenges while also managing risk, quality, GxP and regulatory requirements.
Our commitment is to obtain results and create value. We will do everything to make sure to communicate our excellent professional knowledge, which we have gained over the years, to ensure your achievements and success, while ensuring effectiveness, integrity, professionalism, excellence and quality.
We believe in sharing our knowledge with you so that you can move toward achieving results in the future. At the end of the project, we will provide professional training to your work teams with the aim of maximizing the value and transferring maximum knowledge and independence to you. We believe in a long-term commitment and will assist you with any challenge or need that may arise in the future.
Part of our team
Eran Yona, CEO, GxP Expert, GMP auditor and Manufacturing Technologies
Over 20 years of multidisciplinary experience in pharma and medical industries
Avital L.
Referral Validation and QA
Shay G.
Manufacturing Process Technician, Medical Device and Validation
Bar B.
Business Development
Ronit S.
Regulatory Advisor
Leonid T.
Process & Validation Engineer
Our statistics
What do our customers think?
“Eran from Bio-Chem supported and counseled Medimor Ltd. during its transformation from an antenna manufacturing company named “Galtronics” to a leading medical device turnkey subcontractor in Israel. The project included state of the art clean room facility design and inspection, qualification and GMP training.
I enjoyed working with Eran and the 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 at a satisfactory quality level and in a timely manner.”
“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 the Bio-Chem team. The inspector was well-skilled and experienced, and the inspection was thorough and efficient. Thank you!”
“Eran Yona performed two GMP audits and one ISO audit to evaluate our contractors. Excellent performance, deep cGMP/ISO knowledge, customer orientation and fast communication. Final audit reports were provided in a very short time, and additional questions that I had were answered quickly and accurately. It would be a pleasure to work with Eran again on any project in the future.”
“To the Bio-Chem team: You are professional and relevant, pleasant and courteous. On this occasion we thank you for your support throughout the period we worked together, and we’d love to recommend Bio-Chem as an excellent and professional company.”
“Many thanks to Eran Yona and the Bio-Chem staff. The staff was invited on short notice to a new facility, the work was done professionally while meeting very tight and rigid schedules. A professional team with lots of patience and courtesy. I would love to recommend Biochem as an excellent and professional company.”
“Eran Yona and Bio-Chem have 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.”
“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. All documentation supplied was well written and detailed. Bio-Chem’s support has allowed our organization to complete the project on-time and successfully. Their guidance has improved our company’s regulatory compliance and manufacturing processes.”
Our areas of expertise
Research and development
Consulting in a variety of areas including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and 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 biomed regulations and in accordance with GxP principles.
Manufacture and packaging
Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training and validation of equipment, systems, and production and cleaning processes.
GxP and quality validation
Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, adoption of GxP principles within a company, ISO 13485, quality assurance, preparation for global regulatory audits while conducting risk analysis and evaluation, and validation of equipment, systems, software, testing methods, manufacturing processes, and cleaning processes until a successful audit outcome is received.
Regulation and registration
Regulatory consulting and drug registration, medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, while building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner and in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies up to receipt of approval.
Software and systems
Digital healthcare consulting, software development and medical applications in accordance with FDA 21 CFR Part 11 , EU Annex 11, US HIPAA and EU GDPR requirements, ISO 13485, ISO 27001, ISO 27799, CE marking, risk assessment, and software and control systems verification and validation, up to receipt of marketing authorization.