Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations.
Marketing Authorization Holders (MAHs) must perform a risk evaluation of their medicinal products containing chemically synthesized Active Pharmaceutical Ingredients (APIs) to assess adherence to nitrosamine regulations. The risk evaluation of all products must be concluded by March 31, 2021, at the latest.
Find out how ProPharma Group experts expediently satisfied a request for a risk assessment essential to meeting nitrosamine regulatory requirements.
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