Your needs – Our proven regulation and personal 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?
“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
“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
“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
“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
“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 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
“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
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!
Use our experts to exam your application – Simply contact us with details and attach your document below:
Your document was not approved?
We offer our document review services by our senior consultants at a fraction of the cost you would normally pay or a full refund.
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