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.

Our Client’s Testimonials

    Manager-Regulatory AffairsHead of Regulatory Affairs
  • Aariya’s seamless support in arranging quality labeling, technical inputs, quality review, and most importantly their short turn-around time helped us in timely response to the FDA thereby assisting in securing faster product approval.
    Manager-Regulatory Affairs
    A Malaysian Based Generic Pharmaceutical Company
  • They are great with their prices and excellent with their turn-around times. The most important quality that I like about Sachin and his team is that they would go that extra mile to get the job done and have so far never let us down.
    Head of Regulatory Affairs
    A US Based Generic Pharmaceutical start-up