Case Study
Background
A young pharmaceutical company who develops a new anti cancer product for Leukemia treatment. The company successfully past the per-clinical stages and was looking towards phase I and phase II.
Challenges
- Transfer of laboratory uncontrolled and mini-scale production to GMP large scale
- Equipment specifications
- Pharmaceutical product manufacturing risk assessment
- Pharmaceutical process development
- Equipment and machinery purchasing
- Pharmaceutical process engineering
- Technology transfer and experimental batch manufacturing
- Equipment validation
- Process Performance Qualification
- Cleaning validation and verification
- Storage and shipment validation
- Clean room validation
- Water system validation
- GMP documentation
Testimonial
“Bio-Chem led Tiltan Pharma production for several years and various formulations.They were very professional and instrumental in the preparation for production as well as in the actual production work. Eran was doing all that with a smile, even after long (sometimes very long) hours of work and facing non-trivial challenges”
Clinical Research Director at MSD
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