ECA’s guide to compliant equipment design
By Giuliana Miglierini The legislative evolution of the last decades emphasised requirements for equipment used in pharmaceutical productions.…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment
by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
Key issues in technical due diligences
by Giuliana Miglierini Financial due diligence is a central theme when discussing mergers and acquisitions (M&A). Not less…
Trends in the development of new dosage forms
by Giuliana Miglierini Oral solid dosage (OSD) forms (i.e. capsules and tablets) historically represent the most easy and…