Case Study

Field: Pharma/Biotech/Medical/Cosmetics/Food


GMP printing press and packaging material company for Food/Cosmetics/Pharma and Medical companies


  • Regulatory and Quality consultancy
  • Quality System establishment towards ISO 13485
  • ISO 13485 certification
  • Quality improvement project including GMP implementation and training
  • GMP consultancy
  • Aseptic products GMP manufacturing for clinical trials
  • Regulation
  • Medical Process Engineering
  • Validation consulting
  • Internal quality/GMP audits and inspections
  • New manufacturing technologies consultancy
  • Operational Excellence and Lean project
  • Validation consultancy
  • GMP audits and inspections
  • Quality system policies and documentation preparations
  • Suppliers and contractors Quality audits and certifications

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