Azelix’s team of regulatory experts has an average experience of 25 years in the industry and will work closely with you to ensure that your clinical development program fulfills regulatory, scientific and clinical requirements, as well as, complies with the laws and regulations required by worldwide regulatory agencies. Our regulatory team is able to work directly with regulatory agencies on your behalf.

Azelix’s regulatory affairs services include:

  • Regulatory strategy development
  • IND and IDE submissions and maintenance (including Annual Reports)
  • GCP, GLP and GMP audit
  • Lead and/or participate in Pre-IND and/or Pre-NDA meetings
  • Preparing Pre-IND and/or Pre-NDA briefing packages
  • Responses to FDA inspections (483s) and other FDA correspondences
  • 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