In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International...
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly...
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention...
Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated...
