Case Study

Field: Medical

Background

An international company that develops and manufactures Medical Device in a novel technology

Challenges

  • Quality System consulting
  • Regulatory consulting
  • Unique Medical Device manufacturing technology testing and troubleshooting
  • Validation consultancy

Testimonial

“Bio-Chem’s team is great to work with.They are reliable and very knowledgeable in their field. They have years of experience and are able to advise you on all Pharma and Medical Device” aspects”

Stephen Shattenstein
QA/RA at AB Dental

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