Case Study

Field: Medical

Background

An international company that develops and manufactures medical products

Challenges

  • Quality By Design consultancy
  • Design Control consultancy
  • Regulatory consultancy
  • Qualification and Validation consultancy
  • GMP and Quality consultancy

Testimonial

“Following the completion of a 4 year mega-scale project, developing a new product, I had the opportunity to work with Eran&Bio-Chem’s team on the Design-Control file for the new product. Eran (Owner at Bio-Chem Engineering) led us trough the full process with a very clear and coherent guidance. Showing us the path within a mass of numerous documentations collected during the full process from initiating the new product requirements, up to the completion of the validation of the product, at the end of the delivery of the manufacturing-line to the plant operation facilities. I highly recommend Eran as a skilled professional in the field of compliance and regulatory documentation”

David Molcho
R&D Manager at Albaad-Fem

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