Case Study
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”
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