Case Study

Field: Pharma/Biotech


International Bio-Pharmaceutical company


  • Quality Assurance services and consultancy (QA services and consultant)
  • Quality improvement projects management
  • Bio-Pharmaceutical technology Process Engineering
  • Equipment and system Validation
  • Engineering testing and Commissioning
  • Preparation towards FDA regulatory audit
  • Verification and Validation for Pharmaceutical software and central control system


“Eran and Bio-Chem’s team were instrumental in assisting my group to complete qualification activities prior to, during and after key audits by regulatory bodies. His team was engaged mostly in cleaning validation, equipment validations and various utility validations. The team’s input allowed us to make the progress needed and meet the quality levels expected by the various regulatory bodies during particularly difficult times”

Amitai Itzhakov
process Technology specialist at Omrix

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