Featured Pharma Online Editorial

  1. 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.

  2. Shaping The Future Of GLP-1 Quality 11/4/2025

    Three experts—Doug Bakan (CTO of Kailera), Hyung Heon Kim (CEO of MetaVia) and Deepa Nagpal (Founder of SygnifyQ)—joined us on Oct. 15, 2025, to explore this topic, find out the most common quality failures, learn what innovation is occurring and find out what business decisions can help support both quality and quantity.

  3. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

  4. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

  5. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

  6. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  7. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  8. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  9. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

    The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

  10. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

    Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.