Document Management Systems (DMS) for Pharmaceutical Industry
A 21 CFR Part 11 compliance DMS is part of overall compliance and quality requirements across pharmaceutical organizations. Many tools […]
Pharmaceuticals
Drug Master File (DMF): Meaning, Submission & Guidelines
The critical information about the CMC (Chemistry, Manufacturing and Control) aspect of an active pharmaceutical ingredient or a finished pharmaceutical
Pharmaceutical Excipients: Definition & Types
The main component of a drug product is the active pharmaceutical ingredient (API) but a finished drug product contains ingredients
What Is Investigational New Drug & Types Of IND
The governing federal law makes it a compulsion for the pharmaceuticals to be subject to the marketing application for their
Artificial Intelligence Impact on Global Pharma Regulatory Affairs
Artificial Intelligence (AI) has been making significant strides across various sectors, and the pharma industry is no exception. One area
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
Nitrosamines have emerged as a significant concern in the pharmaceutical industry due to their potential carcinogenic effects. As impurities that
Pharmaceutical Regulations and Registration in Vietnam
Vietnam is the 7th fastest growing middle-class population in the world and aims to achieve an upper middle class income
Pharma Artwork & Labeling Management Software
From content to carton, a pharmaceutical product’s lifecycle includes scientific medical writing from product development (target product profile) to patient
Pharmaceutical Drug Patent Expiry: Price Impact, Regulatory Challenges & More..
Patent expiry marks a significant milestone in the lifecycle of a pharmaceutical product. When a drug is first developed, the