Topic

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The nonprofit is calling upon its community of experts in both artificial intelligence and machine learning to continue building support for responsible adoption of AI in the bio/pharmaceutical industry.

Pistoia Alliance Announces Agentic AI Collaboration Initiative

Digital solutions help pharmaceutical manufacturers navigate the complex supply chain.

Keys to Navigating the Complex Drug Supply Chain

Evonne Brennan, evonne@evonnebrennan.com, is an experienced educator and consultant delivering tailored tuition and courses in pharmaceutical formulation and processing. Evonne is a member of 

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Focusing on the Fundamentals of Formulation

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

Effectively Using Contamination Control Strategies

EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines.

EMA and WHO Celebrate 10-Year Collaboration

Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.

Mislabeling Leads to Cyclobenzaprine Hydrochloride Recall

Patrick Falvey is principal consultant 2 of Chemistry Manufacturing and Controls, Sia/LBG.

Georgia Sloboda is managing director of Chemistry Manufacturing and Controls, Sia/LBG.

Sarah DeDonder, PhD, is manager of Quality Assurance with Sia/LBG.

Lauren Schoukroun-Barnes, PhD, is associate manager of Regulatory Affairs,  Sia/LBG.

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

Fernanda Onofre is global marketing director, Pharma Excipients, HNC at dsm-firmenich.

Jérôme Barra is vice president Global Marketing Taste, HNC at dsm-firmenich.

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes. 

The Role of Flavoring Agents and Taste Modulation Strategies in Drug Development

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

Ask the Expert: Studies for Extractables and Leachables

Cereno reports that its lead program, CS1, demonstrated encouraging efficacy while meeting its primary endpoint of safety and tolerability in a Phase IIa trial.

Quality Systems