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Tag: pharma consultants

How Does a Pharmaceutical Consultant Evaluate Impurities in New Drugs?

How Does a Pharmaceutical Consultant Evaluate Impurities in New Drugs?

Health
During any new drug product development phase, developers have to conduct a degradant and impurity evaluation at varying degrees and several points in the program. An expert pharmaceutical consultant can help in this examination like active API identification as the drug product and substance. Global regulatory agencies like the FDA (Food and Drug Administration) expect recognition, qualification, and reporting of the compounds. It is dependent on the 3 guidance documents by the ICH. A pharma consultant takes the help of these documents at various developmental stages and addresses particular concerns related to specific degradants or impurities. How and when the pharmaceutical consultant will implement the appropriate timing of the guidance documents is crucial for...