Case Study

Field: Pharma/Biotech

Background

Pharmaceutical company

Challenges

  • Quality Assurance support
  • GMP services and consultancy
  • Pharmaceutical production Processes Engineering consultancy
  • Pharmaceutical  process scale up
  • Validation consultancy
  • Process Validation project
  • Cleaning Validation project
  • Quality Assurance services and contractors
  • Validation services and contractors
  • New Pharmaceutical manufacturing facility testing and certification
  • Quality audits and inspections support
  • API supplier Quality audits
  • ISO 9001 and 13485 certification
  • Israeli API and drug manufacturers GMP audits
  • GMP API and excipients supplier audits according to ICH Q7

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