santoshnarla

anda formulations drug ema usfda exclusivity patents generics intellectual property rights regulatory affairs santosh kumar narla anda submissions ucm578368 ucm370352 acceptance for review rtr refuse to receive santosh narla alcoa whistle blowers quality compliance data integrity submission batches exhibit batches process validation manufacturing process drugs elemental impurities q3d heavy metals pharmaceuticals impurities genotoxic impurities marketing authorisation eu regulatory filling european reference decentralised procedure national authorization