[email protected] 

Regulatory Affairs

  • Regulatory strategy at all stages of product life cycle – regulatory submissions, pharma and medical devices (Israel MOH, FDA, EMEA)
  • NDA & eCTD writing and reviewing
  • Lab (GLP) and site (GCP) audits
  • FDA / EMEA meetings and presentations
  • Post-marketing approval maintenance (variations)
  • Pharmacoeconomic submissions (re-imbursement submissions) to the Israel MOH
  • Qualified Person (QP) services

    Regulatory Services

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