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