In the highly regulated pharmaceutical and life sciences sector, the quality of a drug substance or drug product is only as reliable as the analytical procedures used to test it. Historically, analytical methods were developed using empirical, trial-and-error "minimal" approaches, often resulting in rigid methods that triggered extensive regulatory hurdles whenever a minor change was required...
Navigating the global regulatory landscape for generic and innovative drug development requires continuous alignment with harmonized international standards. Adopted across major regulatory authorities—including the U.S. FDA, European Medicines Agency (EMA), and Health Canada—the ICH M13A guideline establishes unified global criteria for conducting bioequivalence (BE) studies on...
For life sciences organizations navigating the complex journey of drug development, manufacturing, and commercialization, compliance is not merely an optional checklist item—it is the ultimate license to operate. At the heart of this compliance framework, particularly within the United States, lies the Code of Federal Regulations (CFR).
For regulatory affairs professionals, mastering the...
In the complex lifecycle of pharmaceutical development, ensuring that patients receive safe, effective, and high-quality medication is paramount. This responsibility becomes even more critical—and tightly regulated—during clinical trials. For investigational medicinal products (IMPs) entering or circulating within the European Union (EU) and European Economic Area (EEA), a...
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