US Agent Services

Our experts offer guidance and strategy to help clients understand and navigate the regulatory challenges that arise during various stages of product development. Our understanding of the regulatory environment in the established market such as USA has enabled us to help our clients in their regulatory filing specifically for US market.

us-agent-service
  • Identification of drug product for filing, market evaluation and coordination with distributor
  • Front End Interaction with FDA
  • Primary Contact with FDA
  • On time Submissions
  • Managing FDA Communications to Applicant
  • Final Approval of ANDA/Follow-ups
  • Coordination for payments of Site Establishment fees per GDUFA
  • Site/Facility Registration with FDA
  • Self-ID submission of the sites
  • Coordination in GDUFA User Fee payment
  • Deficiency response management
  • RLD Samples provision (But cost of RLDs will be actuals)

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