The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...

In March 2022, the ICH Q14 draft guideline was published for public consultation aiming to describe science- and risk-based approaches for developing and maintaining analytical procedure suitable for ...

Indian pharma sees US FDA Q12 guidance as well-defined pathway for regulatory submission. This is reinforced by the efforts of the International Council for Harmonisation of Technical Requirements for ...

Recent regulatory guidance has encouraged a lifecycle approach to pharmaceutical product development. One of the advantages of such an approach, including a Quality by Design (QbD) framework for ...

Recent regulatory guidance has encouraged a lifecycle approach to pharmaceutical product development. One of the advantages of such an approach, including a Quality by Design (QbD) framework for ...