News Articles / Regulatory affairs
by samitfm · Published May 8, 2024 · Last modified January 10, 2025
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...
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...
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...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified December 26, 2024
Module 5 clinical summary report regulatory submission module 5 on clinical summary reports. Module 5 clinical summary report regulatory submission , A clinical summary report is a document that provides a summary of the...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified January 10, 2025
Non-clinical Regulatory affair module 4 Non-clinical Regulatory affair module 4 Regulatory non-clinical Regulatory Affairs Non-Clinical Module 4 is an essential component of the pharmaceutical regulatory submission process. It contains detailed information related to the...
eCTD-module-3-drug-products Understanding the 5 Modules of Regulatory Affairs in eCTD/CTD/ACTD Format-Part 2 eCTD-module-3-drug-products Module 3 drug products eCTD-module-3-drug-products Module 3 of a regulatory submission for a drug product plays a crucial role in the...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified December 30, 2024
Understanding the 5 Modules of Regulatory Affairs in eCTD/CTD/ACTD Format-Part 1 Regulatory Affairs Module 1-Understanding the 5 Modules Understanding the 5 Modules of Regulatory Affairs , the contents of module 1 in regulatory affairs...
News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified January 10, 2025
Regulatory Affairs Requirement for submission dossier Regulatory Affairs Requirement: USFDA Regulatory Affairs Requirement The United States Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of a wide range of...
Clinical Research / News Articles
by samitfm · Published April 27, 2024 · Last modified January 10, 2025
Clinical Study Report-E3 structure Clinical Study Report First, is important to understand the definition, requirements, and potential uses of a CSR. The report is a comprehensive look at all the data produced in a...
Clinical Research / News Articles
by samitfm · Published April 25, 2024 · Last modified January 10, 2025
Clinical Trial Management & Part 11 Compliance Clinical Trial Management Background What is Good Clinical Practice? Clinical Trial Management A process enabling reliable decisions about allowing a medical product to be marketed Product Approval...
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