Neuland is manufacturer of Active Pharmaceutical Ingredients and provider of Contract Research Services. Neluand has been Preferred Source world wide for APIs and Intermediates for over 25 years.
Knowledge of China registration activities will be an added advantage for the China section. Basic knowledge of ICH Guidelines and API regulatory requirements.
Coordinate with production and PPIC team for Mfg. area allotment Execute technology transfer activities from R&D to manufacturing for formulation products, ensuring smooth scale-up and process transfer
Data entry of safety data onto adverse event database and tracking systems.Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.