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Published at: 15th April, 2025 In a fast-evolving pharmaceutical landscape, strategic insights are no longer a luxury—they are essential. Whether you're planning a product launch, evaluating a pipeline molecule, or eyeing global markets, having accurate, evidence-backed intelligence can make all…
December 16, 2024 In a significant move to support patients battling rare diseases, the Central Drugs Standard Control Organization (CDSCO), India’s apex drug regulatory body, has directed drug regulators across the country to fast-track the approval process for medications and…
Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical composition of the material in question. In pharmaceutical preparations, impurities identification, assessment and quantification play a vital role in evaluating…
Aug, 23 2021 USFDA approved the first fully licensed COVID19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of…
“Audit is a systematic, independent, and documented assessment to determine whether agreed upon requirements are being met and will continue to be met”. In the present article we shall be able to understand the Basics of audits and Key Roles…