Consultancy services2022-01-28T23:07:05+00:00

Consultancy Services for Biomed & Digital Health Industries

Bio-Chem Ltd. (2007) provides Consultancy Services on product development, technology, facility design, regulation and registration, quality, GxP and manufacturing to biopharma, medical device, digital health, and dietary supplement companies.

Consultancy services - Bio Chem
Consultancy services - Bio Chem
Consultancy services - Bio Chem
Consultancy services - Bio Chem
Consultancy services - Bio Chem
Consultancy services - Bio Chem

    Contact us

    Contact us

    development of medical products

    We advise and accompany our customers from the product development stage, choosing the most appropriate technology, building the product portfolios and technical portfolios, building the quality system, employee training and certification, submitting to the health authorities and registering the products, validating and verifying, adapting the company to GxP requirements and guidelines, In production, performing analysis and risk assessment, project management and more.

    We consider it very important to provide a professional, cost-effective and efficient response to our customers without compromising on quality issues

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    About Bio-Chem

    Our consultancy services

    Bio-Chem offers a wide range of professional services, courses, training, and advice at the highest professional levels, with a focus on the customer and emphasis on quality and regulatory requirements, all while embracing innovation alongside efficiency to maximize value for our customers.

    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, validation of equipment, systems, and production and cleaning processes.

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    GxP, quality and validation

    Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until  a successful audit outcome is obtained.

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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, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval  (marketing authorization) is received.

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    Software and systems

    Digital healthcare consulting, software development and medical applications in accordance with US  FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.

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    Why should you work with us?

    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.

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

    • Proven track record in audits by 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

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

      Our clients

      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
      Consultancy services - Bio Chem

      “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
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