by Valeria diGiacomo | 27/05/2026 | Scientific writing
The discussion around AI-Assisted Regulatory Writing has quickly moved beyond simple questions of efficiency. The real challenge today is not whether AI can generate text, but whether it can support the scientific and regulatory coherence and integrity required across...
by Valeria diGiacomo | 05/03/2026 | Scientific writing
In today’s global clinical development environment, regulatory operates within a framework defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and enforced by authorities such as the U.S. Food and...