Regulatory Due Diligence

Reguliance provides regulatory due diligence services to pharmaceutical and biotech companies, investment banks, legal firms, and other consulting firms.

Areas of expertise include:

  • Overall development plans and regulatory strategy
  • Small molecule chemistry, manufacturing, and controls, including proposed changes to CMC
  • IND, NDA and BLA regulatory evaluation

Areas of specialty include:

  • Respiratory and nasal delivery products and delivery systems
  • Lung surfactants
  • Stability requirement evaluation
  • Extractables and leachables evaluation