About us2020-09-16T10:28:06+00:00

About us

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.

Company clients

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 

Successful international regulatory audits 98%
Launching innovative technologies 96%
Satisfied & returning clients 92%
Facility & laboratory approvals by health authorities 99%
Successful innovative product submissions 95%
Successful product & process improvements 100%

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.”

Ofer Sagi Quality Engineering Manager, Johnson & Johnson

“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!”

Dr. Gali Guzikevich Sr. Director GMP QA, Innovative R&D, Teva

“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.”

Georgy Laskov QP, Zoetis

“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.”

Dr. Yael Koresh QA, Minipac

“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.”

Simha Vazana QA Manager, Phibro

“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.”

Adrian Harel CEO, Medicortex Finland Oy

“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.”

Inbal Kapry Barel Sigma Aldrich
More recommendations for Bio-Chem

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.

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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.

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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.

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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.

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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.

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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.

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You are invited to contact us

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