News You Can Use

The Yakatan Rules for Pharma R&D Efficiency will be shared with our readers in a series of blog posts. They are the opinions of Dr. Yakatan, based on biases accumulated over 40 years of involvement with R&D structures and managements. The Yakatan Rules are extracted from his popular seminar, “Where Have All the New Drugs Gone: A Model for Improving the Efficiency and Costs of Pharmaceutical R&D.”

Staying Knowledgeable About FDA Changes

January 31st, 2018
Are you developing a new parenteral formulation?  An orphan drug or a drug delivery system? Are you working on a clinical trial design? If you’re involved with the development of new drugs, you’re probably keenly aware that the U.S. Food and Drug Administration (FDA) review process is vital for you, but you may not have …

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Are you new to the concept of Current Good Manufacturing Practices (cGMPs)?

November 9th, 2017
IRISYS’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials and commercial pharmaceutical products. The cGMP manufacturing team complies with IRISYS’ rigorous Standard Operating Procedures and FDA Guidelines. The Facts About the Current Good Manufacturing Practices section of the FDA website …

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