Saturday, December 27, 2008

Phase 1 Clinical Safety Data - How to Submit to FDA?

From the desk of Dante.

During negotiations with FDA, now preparing for submission activities - did you ever get a letter from FDA, pertaining to your safety data and asking for "some" pooling of safety data across all Phase 1 studies? In other words, a Phase 1 global integrated safety database?

Shocking isn't it?!

Friday, December 26, 2008

Importance of Clinical Overview eCTD Module 2.5

Welcome back to Dante's Blog. This is written by the President of Dante.

eCTD Module 2.5, the Clinical Overview {CO}, is one of the most important documents in any regulatory submission. CO M2.5 provides FDA with its first impression pertaining to the merits of the drug filed, its quality, content and indication positioning. A "poor" CO will not trigger a refusal to file {RTF}. A CO without quality and content will have a convoluted path to approval.

Remember - There is no short-cut to quality. Quality control ensures the integrity of your data.

Realize ROI - return of investment. Most pharmaceutical sponsors do not understand the importance of the CO. Most do not know the ROI on utilizing QC early.

Contact us.

Tuesday, December 16, 2008

Drug Development and Regulatory Submissions Blog

Welcome to Dante Resources, Inc. We hope you've had a chance to examine our support services for clinical drug submissions and hope you return often.See our ROI/Quality Page