Anvisa RDC 964/2025: What you need to know about the latest regulatory update
The Brazilian Health Regulatory Agency (Anvisa) has introduced RDC 964/2025, a new guidance that outlines in more detail the requirements for conducting forced degradation studies. This new regulation replaces RDC 53/2015, aligning the requirements for forced degradation studies with international (ICH) standards. By reacting to these regulatory changes, Lhasa has evolved our solution for predicting […]
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