1. Planning and execution of projects
  2. Monitor project time lines
  3. Regulatory and compliance risk assessment
  4. Outsourcing management
  5. Supporting product management initiatives
  6. Workshops and cGMP trainings
  7. Product life cyle management
  8. Product quality reviews (system design and implementation)
  9. Manufacturing process reviews
  10. Process ad analtical method transfers between manufaturing sites and analytical labs.
  1. Regulatory submissions
  2. Risk Assessement: complaints, deviations, and CAPAs management
  3. Quality processes mapping and optimization
  4. Validation: Facilities, equipments, methods, and analytical labs from design to process verification (PV)
  5. Contractors management through on-site audits
  6. Drug stability program management
  7. Monitor project timelines
  8. Analytical labs, CMO’s, and contractor packaging management
  9. Drug supply chain manament: 3PLs, Warehouse, distribution centers and affiliates