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Regulatory Affairs Services

Our regulatory affair team values and cultivates long-term client relationships and strives to function as an integrated and value-added extension of the Sponsor’s regulatory team framework.


Our industry experts are skilled in providing end-to-end regulatory support from managing, preparing and submissions to regulatory authorities.


Regulatory affairs team provides the critical interface between the client and regulatory authorities.


Our team’s acumen and problem solving skills warranty query resolution and compliance for timely regulatory approvals.


  • Regulatory Intelligence
  • Clinical Development Strategy
  • Expedited Strategy
  • Label Development
  • Regulatory Compliance
  • Regulatory Document Publications
  • eCTD Submission
  • CMC


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