Our team of regulatory experts will work with you closely to ensure that you fulfill regulatory, scientific and clinical requirements and comply with the laws and regulations required by worldwide regulatory agencies. We will put together a regulatory service package based on your regulatory and strategic goals. Azelix regulatory team works directly with regulatory agencies on your behalf. Below, you will find summary of services provided for our clients:

  • Regulatory strategy development
  • IND and IDE submissions and maintenance (including Annual Reports)
  • GCP, GLP and GMP audit
  • Develop strategy and run Pre-IND, Pre-NDA meeting
  • Pre-IND, Pre-NDA briefing packages
  • Presentations to the FDA
  • Negotiations with FDA
  • Responses to FDA inspections (483s) and other FDA correspondence
  • 505(b)(2) strategy and NDA submission preparation
  • eCTD preparation: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISS, ISE, 505 (b)(2) summaries)
  • Due diligence for technology licensing
  • Toxicology package development
  • Scientific & Strategic Consultation