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Dessi McEntee, MS, DABT
Fractional Chief Development Officer
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Regulatory Strategy


Preparing for International Submissions: The Toxicology Perspective
Discover essential products for nonclinical safety and toxicology in drug development.

Dessi McEntee
1 day ago6 min read


The Crucial Influence of FDA and EMA Guidelines on Safety Assessment in the Pharmaceutical Industry
Discover products related to FDA and EMA guidelines in safety assessment.

Dessi McEntee
6 days ago6 min read


Navigating the Toxicology Regulatory Landscape: Your Essential Guide
Discover essential products for navigating the toxicology regulatory landscape.

Dessi McEntee
Jun 55 min read


The Essential Role of Toxicology in New Drug Applications
Discover products that support nonclinical safety and toxicology in drug applications.

Dessi McEntee
May 315 min read


Navigating the Seas of Nonclinical Study Reports: Your Guide to Regulatory Compliance
Discover products to support your nonclinical study reports and drug development.

Dessi McEntee
May 266 min read


The Crucial Role of the FDA in Nonclinical Safety: Navigating the Toxicology Landscape
Discover products that support nonclinical safety in drug development.

Dessi McEntee
May 126 min read


The Crucial Role of Regulatory Agencies in Drug Development
Discover products that support your knowledge of regulatory agencies in drug development.

Dessi McEntee
May 116 min read


Understanding GLP (Good Laboratory Practice) Standards: A Guide for the Pharmaceutical Industry
Discover products that support your knowledge of GLP standards in drug development.

Dessi McEntee
May 15 min read


The Impact of Toxicology Data on Regulatory Approval
Discover products that can deepen your insights into toxicology and regulatory approval.

Dessi McEntee
Apr 96 min read


Study Sequencing: The Study That Should Have Come First
Most nonclinical teams spend a lot of time thinking about which studies to run. Very few spend enough time thinking about when. Study sequencing is one of the most consequential — and most underestimated — decisions in IND-enabling development. Get the order right and your program builds on itself. Get it wrong and you're defending conclusions built on shaky ground. This issue breaks down the 3 sequencing mistakes I see most often.

Dessi McEntee
Mar 65 min read


“No Major Findings”: The Hidden Risk
"No major findings" is one of the most reassuring phrases in nonclinical development — and one of the most dangerous. It describes what wasn't observed. It doesn't interpret what the study actually resolved. Once that phrase enters the conversation, attention shifts, assumptions harden, and questions stop being asked. This issue unpacks why clean studies require more interpretation, not less.

Dessi McEntee
Feb 203 min read
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