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 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.