thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

ANDA NDA

February 5, 2020

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...

ANDA NDA

February 27, 2018

Drug Development: The Key to Success from Concept to Commercialization

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?”....

ANDA NDA

May 14, 2015

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...

Prev 1 2

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.