Pharmaceutical Regulatory Affairs and IPR

Regulatory submissions today fall under pretty strict standards: If it isn’t an eCTD (electronic Common Technical Document) it’s still likely to be based on the CTD, whether it’s electronic or not. Harken back to the days when publishing involved custom software; where a submission could mean shipping 150 pounds of equipment, or transporting multiple laptops across international boundaries; where reviewer demands could involve a 6AM phone call and a 7AM plane ticket. But it wasn’t all bad: the early days of electronic submissions resulted in an unprecedented level of interaction between reviewers and

regulatory and led to our modern standards.