Case Study

Field: Pharma/Biotech/ Medical

Background

Pharmacology preparations facility which include clean rooms for special home medical treatment dosage forms manufacturing and imported medical and drug products labelling, packaging, storage, distribution and logistics.

Challenges

  • Quality and GMP consulting
  • Manufacturing facilities and clean rooms design
  • Medical and drug products shipping and GDP consulting
  • New labelling and packaging technologies consultancy
  • Operational Excellence and Efficiency Improvement project
  • Warehouse Validation and certification
  • Pharmaceutical and medical products Shipping Validation
  • Quality and GxP training
  • Pharmaceutical and Medical Process Engineering
  • Warehouse Validations
  • GMP and Quality System training

Testimonial

“Bio-Chem has supported Neopharm group mostly in process engineering, validation, GMP and quality issues in the bio-pahrmaceutical fields as well as Medical Devices.

Bio-Chem has also participated clinical batch manufacturing including aseptic production and media fill simulations.

Bio-Chem team are very experienced, qualified, reliable and talented consultants”

Eran Efroni
Operation manager Instrumetrics

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