Case Study

Field: Pharma/Biotech/Medical


Multi-national Medical and Bio-Pharma company


  • Manufacturing Process Engineering
  • Quality Assurance services (QA)
  • Utilities and manufacturing equipment Validation
  • Project management
  • Commissioning, Qualification and Engineering testing
  • Software Verification
  • Software Validation
  • Control and Automation systems Verification
  • Control and  Automation systems Validation


  • “Bio-Chem team is well rounded in Quality and Validation services to BioMed industries. Bio-Chem team is highly professional and highly service orientated in delivering Quality and Validation assignments”

    Moshe Radovitch
    Cyber Security CEO at Tera-zone
  • “I am working with Bio-Chem for the last three years on a scale-up and tech transfer and validation of manufacturing process of 2 sterile biologic products. This project contains complex customized equipment, ISO 6 clean room construction and qualification, process development, Control and Automation and etc. Eran and his team were deeply involved on the commissioning of clean utilities, clean room HVAC system, process equipment, computerized system validation, software validation, control and automation systems verification and validation and quality assurance services. Eran served both as mentor to his team (training, guiding, directing, knowledge, solving problems and etc.) and also supported directly different critical activities were hands-on complicated and time constrain activities were required. Bio-Chem provide high quality performance and documentation with complete accountability to time and budget”

    Yaki Sidis
    Project Manager at Omrix, a Johnson & Johnson company

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