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    Your needs – our proven regulation and professional capabilities

    Bio-Chem Ltd. (2007) supports Bio-Med clients worldwide with quality, regulation, information security, validation, controlled documents, and much more.

    Bio-Chem holds an unmatched 99% success rate of regulatory approvals for nearly two decades in the most challenging Bio- Pharma, Medical and Digital Health industries

    GXP | ISMS | ISO | MEDICAL CANNABIS | QMS | RISK ASSESSMENT | VALIDATION | CONSULTATION

    What do our customers think?

    What do our customers think?

    “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”

    Georgy Laskov, QP at Zoetis

    “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. Thank you!”

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

    “Many thanks to Eran Yona and the Bio-Chem staff. The staff was invited on a short notice to a new facility, the work was done professionally while meeting very tight and rigid schedules. 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 the Bio-Chem team have consulted for Sigma Aldrich on GMP and Validations towards 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

    “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”

    Ofer Sagi, Quality Engineering manager at J&J

    “For the Bio-Chem team, working with you is professional and relevant, with a pleasant and courteous reference. On this occasion, we thank you for your support throughout the period we work together, and we would love to recommend Bio-Chem as an excellent and professional company.”

    Dr. Yael Koresh, QA Minipac

    “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”

    Adrian Harel, CEO at Medicortex Finland Oy


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    Utilize Decades of Experience

    If you struggle to complete your application we offer additional support and advice for all your regulatory needs.

    • Professional support, including mock audit and Q&A sessions

    • Final review by our in-house experts before final approval

    • Clear instructions for document customization for your specific needs

    • Customised document writing based on specific needs

    We have attained our expertise over 15 years of proven international regulatory and consultancy capabilities, gained via over 1000 projects!

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    Application Review 

    Use our experts to exam your application – Simply contact us with details  and attach your document below:








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