Company Profile

Bio-Chem Ltd. (Israel 2007) provides Product & Process Development, Regulation& Submission, GxP, Validation, Quality, Engineering, Project Management and Operational Excellence services & consultancy for companies from the Pharmaceutical, Biotechnology, Medical Device, Cosmetics and Food industries.

Bio-Chem brings a fresh, client oriented and professional approach to its consulting and services, focusing on quality, innovation and efficiency for maximizing the value created to our customers. The Bio-Chem team is committed to make the necessary efforts to exceed the expectations of every client by offering outstanding customer service, cooperation and flexibility; assisting our clients achieving the technology, regulatory, quality and other milestones in a timely manner. We specialize in multi-field Bio-Medical project management; working closely with the regulatory bodies, design new Pharmaceutical and Medical plants construction and qualification projects, quality systems establishment and improvement, manufacturing processes troubleshooting and optimization, validation, operational excellence etc. Our consultants and engineers have many years of experience in the industry and are distinguished by their quality, mission oriented and technical expertise combined with hands-on experience in hundreds of projects executed by the company over the years. Bio-Chem’s track record and reference list shows more than 80 clients of which 90% are returning customers.

Bio-Chem is involved in every stage from the early stage of fundraising, new product development, pre-clinical/clinical trials, regulation, submission, process and technology, engineering, documentation, GxP, quality assurance, validation, FDA/CE/ISO inspections and planning an authorized, qualified production site.

Bio-Chem mission

Bio-Chem mission is to guide and assist young as well established Pharmaceutical, Biotechnology, Medical Device, Cosmetics and Supplements companies, facing new Engineering, Process, Technological, Regulatory and Qualification challenges via Risk Management and GxP compliance approach. Bio-Chem is results and value creation oriented. It is focused on delivering a meaningful positive impact for its clients through high level, professional services. Bio-Chem team will manage and document the risks, develop success metrics and define timelines before project initiation in order to assure client’s desired outcomes will be achieved completely. Bio-Chem is committed to client being better off after project termination by significant value creation that will withstand future audits well into the future.

Company Services

Bio-Medical and Cosmetic Operational Excellence, Process Efficiency and Quality level improvement projects. Minimizing time waste and rejected products, reducing setup and cleaning process times and maximizing process yields using 6-Sigma, 5S, best lean etc

 

New Bio-Med facilities projects management, design and manufacturing technologies. Regulatory requirements analysis, Good Engineering and Manufacturing practices consultancy. Escort until successful regulatory bodies audit and certification

FDA/Eu/ISO regulatory compliance consultancy. Quality System establishment, Quality policies/Good Practices integration and training. Quality improvement projects, GMP materials and components suppliers, manufacturing and shipment certification

Software, analytical methods, equipment, manufacturing and cleaning Verification & Validation consulting for Pharmaceutical/Medical products development, production, packaging, sterilization, storage & shipment

New Drugs, Medical Devices prototype and Cosmetics FDA/Eu submission, regulatory requirements analysis, files preparation, regulatory strategy, registration consultancy until certification and marketing approval

Bio-Medical Engineers and Bio-Pharmaceutical researchers escort, support and consultancy from new Medical Device / drugs development until clinical trials, manufacturing technologies development, scale up and GMP certification

Owner

Eran Yona, B.Sc, MBA

Technology & GMP consultant

Eran has more than 17 years of experience in the fields of Biotechnology, Medical and Pharmaceutical industries in Israel.

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Our Team

Ofir Levi

Analytical methods development and validation

He.Maya

Regulation and QA consultant

Smadar Seri

Computerized systems, software, control and Medical applications Validation

Sagi Ofer

Risk Management analyst, Safety, Quality and control systems Validation Engineer

Shay Golan

Process, Validation and Medical Device technician

Noa Cohen