Regulatory Pharma Blogs
Regulatory affair eCTD compilations eCTD compilations The electronic common technical document (eCTD) is a standard format for submitting regulatory affairs documentation to regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The eCTD is an electronic format for organizing and submitting regulatory documents for a drug product …
CMC regulatory affairs: An introduction to CMC and compliance CMC regulatory affairs CMC Regulatory affairs is an important component of the development and approval of pharmaceutical and medical device products. The process of regulatory affairs can be complex and time-consuming, but it is necessary to ensure the safety and efficacy of these products. This paper …
eCTD Regulatory affair & ICH-GCP eCTD Regulatory affair & ICH-GCP Regulatory affairs is a critical component of clinical research and drug development, as it involves ensuring compliance with relevant regulatory requirements and guidelines. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed guidelines for Good Clinical Practice …
Basaglar and Toujeo are both long-acting insulin formulations used to treat diabetes. Basaglar is a long-acting insulin-Basaglar and Toujeo Basaglar is a long-acting insulin that is structurally similar to insulin glargine (Lantus), and is used to control high blood sugar in people with type 1 diabetes and type 2 diabetes. Basaglar is taken once daily, …
AstraZeneca has acknowledged that its vaccine may lead to clotting, but there\’s no need for panic among Covishield vaccine recipients in India. AstraZeneca has acknowledged that its vaccine may lead to clotting, but there\’s no need for panic among Covishield vaccine recipients in India. AstraZeneca, a leading global pharmaceutical firm, has acknowledged a rare side …