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Meranda Parascandola

March 4, 2021

Published by Meranda Parascandola at March 4, 2021

Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

With comprehensive, integrated CMC Regulatory Strategy, emerging sponsors gain greater insight into their Drug Development programs, avoiding bottlenecks and mitigating risks before they lead to mistakes and costly delays. Boost your compliance performance across the complete lifecycle. Ensure consistency and quality in every transaction.

April 6, 2022

Published by Meranda Parascandola at April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.