A Brief History of Bringing to Market a Hugely Successful Containment Transfer System

Ezi-Dock Systems in Kirby in Ashfield, Nottingham, UK, specialises in the provision of liquid- and dust-free powder transfer and handling solutions. Editor Elizabeth Valero visited Ezi-Dock’s Managing Director Steve McAleavy to learn about the... more »

Jan 31, 2014 in Editor's Blog

What Pharma Companies are Doing to Avoid Another Cliffhanger

Haydn Evans is Vice President of Intellectual Property Solutions at CPA Global, one of the world’s leading providers of IP management software and services. Haydn works with a range of clients in sectors such as technology, telecommunications... more »

Jan 31, 2014 in Guest Blogs

The Biopharmaceutical Classification System — Is it Accepted?

The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of... more »

Jan 31, 2014 in Regulatory Affairs Blog

Penn Pharma’s COO Provides Behind-the-Scenes Tour of High Potency Facility

On 26 September, CMO Penn Pharma celebrated the official opening of its £14 million high containment facility for oral solid dosage products in Tredegar, Wales, UK. Editor Elizabeth Valero spoke to Penn Pharma’s COO Mark Dean-Netscher. more »

Nov 26, 2013 in Editor's Blog

What Is a Well-Established Use Application and When Can it be Used?

The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance. more »

Nov 26, 2013 by in Regulatory Affairs Blog

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