GAP begins a risk management program with classification and evaluation of risks related to the products. GAP works with sponsor to expand different goals related to the reduction of risk via execution of various risk management plans. GAP team will help sponsor to actively monitor, review, the risk profile of different products and provide metrics to evaluate the results and efficiency of various risk management plans. FDA requires Risk Evaluation and Mitigation Strategies (REMS) of the product; REMS is an approach which is implemented to handle an identified or probable serious risk related to the products. If any product does not meet the requirement, GAP will provide guidance and helps to improve.
GAP’s Risk Management Services includes:
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