Sterile Drug Products (Includes parenterals, ophthalmics and nasals)

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  • Successful CMC (Chemistry. Manufacturing & Control) product development. Includes IV, IM, SC and extended release formulations.
  • Includes all phases of product development including preclinical, early phases & clinical phases of innovative drugs plus generic drug products of various types such as solutions, suspensions, emulsions, liposomes & device/drug combinations
  • Pre-formulation, and formulation development
  • Container/closure system and package development,
  • Analytical and microbiological  development  
  • Aseptic manufacturing, and sterilization processes
  • GMP compliance for clinical and commercial manufacturing
  • Stability testing as per ICH  
  • Scale-up, process development & validation
  • QC product release and stability testing
  • Specifications and  test methods .
  • Assistance in the development of detailed CMC product development strategies,  plans, risk assessment evaluation/options
  • Technical documents and reports as needed.