Spring Intro 2023

03/03/2023

Common Deficiencies Drug Product

• Most common / most critical deficiencies

03/03/2023

33

33

• Pharmaceutical development (Drug Substance, Excipients, Formulation & Manufacturing Process Development, Overage vs. Overfill, Container Closure Suitability)

Regulatory Agency

MAH (Applicant)

03/03/2023

34

34

17

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