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Bio-Chem Ltd. (2007) provides consulting services on product development, technology, facility design, regulation and registration, quality, GxP and manufacturing for Bio-Pharma, Medical Device, Digital Health, and Dietary Supplement companies. Bio-Chem offers a wide range of professional services, courses, training, and advice at the highest professional levels, with focus on the customer and emphasis on quality and regulatory requirements, all while embracing innovation alongside efficiency to maximize value for our customers.

About us
What do our customers think?
Our courses

Our industries & expertise

Our services

360-degree vision solutions, available 365 days a year, 24/7

Our unique work methodology, based on many years of industry experience, combines professional and practical knowledge, minimizes regulatory and business risks, improves productivity and maximizes customer value.

Research and development

Consultancy in a variety of areas including design, research labs and clean rooms, development technologies, investor business presentations, regulatory strategy, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC, 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 the biometrics regulation and principles and in accordance with the GxP principles.

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Manufacture and packaging

Consultancy in manufacturing plant design, development and engineering of manufacturing processes, selecting the most appropriate technology, process gable, technology transfer, GMP, process improvement, utilization optimization and improvement, employee training and equipment validation, systems, production processes and cleaning.

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GXP, Quality Validation

Advises, establishes, accompanies and upgrades systems of various types of quality management, executes GMP trainings and courses, assimilates the company’s GxP principles, ISO 13485, assures quality and prepares for global regulatory audits while conducting risk analysis and evaluation, equipment, systems, software, testing methods, manufacturing processes. And cleanliness until successfully audited.

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Regulation and registration

Regulatory consulting and drug registration, EMC, CE Mark, nutritional and cosmetic supplements in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and requirements in a professional manner, in a short time, outlining the product, shelf life and graphics, import certifications and meetings with regulatory bodies and up to approval .

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Software and systems

Digital healthcare consulting, software development and medical applications in accordance with 21CFR part 11 / Annex 11 / HIPAA / GDPR requirements, ISO 13485/27001/27799, CE marking, Risk Assessment, and software validation and control systems up to marketing approval.

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How can we work together?

Why should you work with us?

  • Accumulated experience in hundreds of projects in Israel and around the world with over 90% returning customers

  • Proven track record in audits of international regulatory bodies

  • Eran Yona, the company manager, is professionally involved in every project

  • We provide training, guidance, and courses in a variety of relevant areas

  • We are a high-class company focused on innovation, technology, and personal relationships with our customers

  • We are a small, dynamic, innovative, efficient, and professional company

  • We are results-oriented and value-creating for our customer

  • You will receive solutions, results, and advantages while conforming to effectiveness and cost-benefit considerations

  • You will receive high-quality personal care, flexibility, and service

  • You will receive professional training from us at the end of the project at no additional cost

  • You will receive a 10 year guarantee on the outcome and success in any regulatory requirements

More about us
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Years of experience in medical & pharmaceutical
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Clients from all over the world
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Satisfied & returning clients
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Success in regulatory approvals

Our clients

What do our customers think?

“Eran from Bio-Chem supported and counseled Medimor Ltd. during its transformation from an antenna manufacturer 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 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

“Thanks to the Bio-Chem team. You worked professionally and were engaging, pleasant and kind. We thank you for your support throughout the period we worked together, and would love to recommend Bio-Chem as an excellent and professional consulting company.”

Dr. Yael Koresh QA, Minipac

“Many thanks to Eran Yona and the Bio-Chem staff. The company was invited on short notice to our new facility for an FDA inspection. The job was done professionally while meeting very tight and rigid schedules. We worked with a professional team with lots of patience and courtesy. I would love to recommend Bio-Chem as an excellent and professional consulting 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 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
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