Sterile Drug Products (Includes parenterals, ophthalmics and nasals)
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