Featured Pharma Online Editorial
-
Unpacking The EU's Mutual Recognition Agreements For Pharma
12/12/2025
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
-
It's Copy/Paste In Fleet Management Manufacturing
12/11/2025
Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.” In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.
-
FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
12/11/2025
The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.
-
Lessons In Quality From Sanofi's Plai.qa
11/24/2025
The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.
-
Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
11/21/2025
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
-
Here's What You Need To Know About The Access Consortium Pathway
11/20/2025
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
-
Is Charisma An API?
11/19/2025
After nearly 20 years in the pharmaceutical industry, Samir Shah, director of regulatory CMC for medical products and combination products at AstraZeneca, knows how beneficial charisma can be for the pharmaceutical professional. That’s why he presented the topic at the 2025 RAPS Convergence.
-
Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
11/18/2025
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
-
How To Improve Sponsor–CMO Collaboration Around Digital Deviations
11/17/2025
Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.
-
Global Implications Of Zero Tariffs On Indian Pharma Exports To China
11/5/2025
Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.