Risk Evaluation and Mitigation Strategy
AARIYA offers specialized Regulatory Labeling services encompassing original submissions, deficiency response management and life-cycle maintenance of your products
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Risk Evaluation and Mitigation Strategy (REMS)
- Preparation of REMS for Generic companies in line with innovators REMS.
- Supporting Generic companies to develop Single-Shared REMS in coordination with innovator companies and FDA.
- Continuous monitoring of FDA’s REMS website for the REMS revisions/ modifications.