Category: Biopharma

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was...

The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring...

ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stability studies of active pharmaceutical ingredients (IFAs), and of new, innovative, generic, similar,...

Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a...