Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Laureate Approved For eCTD Regulatory Submissions | Contract Pharma

What are you searching for?

Sign in
Breaking News

Laureate Approved For eCTD Regulatory Submissions

RSG offers complete regulatory submission service

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Laureate Biopharmaceutical Services’ Regulatory Services Group (RSG) has been approved by the FDA to submit electronic common technical document (eCTD) regulatory submissions. The four-gigabyte test submission comprising CMC, preclinical and clinical data was reviewed, validated and approved without errors.

“This is a major milestone towards completing Laureate’s strategy of offering clients submission-ready chemistry, manufacturing and control (CMC) reports, as well as providing a complete regulatory submission service,” said Robert Burford Ph.D. vice president Regulatory Services. “Clients will now be able to have their regulatory submission services provided by Laureate independent of having clinical supplies manufactured by us.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics