Case Study

Field: Pharma/Biotech

Background

Pharmaceutical products CMO

Challenges

  • Regulatory guidance
  • New Pharmaceutical products development
  • New Pharmaceutical processes development
  • Clean room facility design
  • New manufacturing technologies consultancy
  • GMP sterile clinical batches manufacturing
  • Tablets manufacturing for clinical trials
  • Pharmaceutical process engineering
  • Pharmaceutical processes scale up
  • Quality Assurance services and consultancy
  • GxP consultancy
  • Validation consultancy
  • Validation protocols writing
  • Validation execution
  • Engineering and technical services
  • Quality training

Testimonial

I enjoyed working with Bio-Chem and Eran Yona. They performed excellent professional work according to defined and well-written study plans, delivering on time all the required services in several pharmaceutical manufacturing and validation projects”

Shimon Amselem
Chief Scientific Officer at Space Pharma SA

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