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 […]
Pharmaceuticals
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 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
Pharmaceutical Packaging Graphic Design – Challenges and Remediation
Pharmaceutical companies face several key challenges when it comes to packaging graphic design. Here are some of the challenges and
Quality System Regulations (QSR) under 21 CFR Part 820
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and
eCTD Structure & Submission Process
Common Technical Document (CTD) is a common standard format for submitting regulatory documents to the respective regulatory authorities for gaining