Importance and quality assessment of raw material suppliers

Importance and quality assessment of raw material suppliers

Make known the importance of the evaluation of raw material suppliers in the pharmaceutical industry, specifically.  Objectives:  Know the complete procedure carried out by large pharmaceutical companies to select suppliers of raw materials. Evaluate the impact of the Supplier/Vendor Selection and Qualification on the quality of the finished product. Know the advantages of an adequate evaluation of…

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pma submission

Importance of FDA Pre-Market approval

Premarket authorization (PMA) is a method by which the Food and Drug Administration reviews new medical devices and drugs. PMA is only allowed if the manufacturer can demonstrate safety and efficacy through “sufficient and well-controlled” studies conducted under harsh clinical conditions. Only then can the manufacturer start selling the product. A pma submission is required for any…

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Clinical Trial Designs

Navigating the Maze of Adaptive Clinical Trial Designs

Unfavorable results during the clinical phase studies will put a damper on the drug’s journey to market. Traditionally, pharmaceutical manufacturers should have a clear hypothesis and realistic endpoints of the trial. An adaptive design clinical trial allows more flexibility in clinical studies by allowing modifications to the trial. The modifications can be done after the…

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