Clinical Research Solutions
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
Quality & Compliance
Drug Development: The Key to Success from Concept to Commercialization
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science behind getting to this stage of having multiple...
Clinical Research Solutions
FDA Sets A Deadline For Electronic Submission Of Drug Applications
In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...