Several European regulators provide perspective on the use of mechanistic models in a complex generic drug development.

AI has the potential to greatly impact the regulatory affairs industry by helping with decision-making, detecting deficiencies in documentation, and automating tasks such as document generation and regulatory updates. It can also be used in collaboration with other companies and manufacturers to improve work efficiency and gain insights into drug content and public perception.

A distribution plan should be prepared, including the target groups, the method and timing of distribution.

Unlike the previous practice, raw data are now stored in electronic structured formats.

The draft guideline covers the scientific and technical aspects of study designs used to support BE assessments.

Billev Pharma East can act as an authorised representative to assist you in complying with European legal requirements.

Today, the European Commission has proposed an extension of the transition period to certify medical devices.