Regulatory Consulting and It Involves Categories

Regulatory Consulting and It Involves Categories

As FDA regulatory consultants since 1999, BTGI has consistently engaged with the FDA in meetings and negotiations on behalf of their clients. The THEM. They are worldwide in giving FDA administrative counseling administrations to European, Indian and other Asian medication designers looking for presence. Their specialized topics incorporate, yet are not restricted to following categories given…

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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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