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Regulatory Affairs

ProSciento’s comprehensive services include regulatory strategies and operations throughout an asset’s development path. Our team works with clients, large and small, to create customized, scalable regulatory programs to address regulations and clinical research requirements specific to investigational drugs and devices for metabolic diseases.

Our Regulatory Services:

  • Analysis of global regulatory options and paths
  • IND/CTA and NDA/ANDA readiness assessment
  • Assembly and submissions of INDs and IDEs
  • Assembly and submission of meeting requests and briefing documents
  • Representation of clients with regulatory authorities