The FDA has approved the application from Laureate Biopharmaceutical Services for an Electronic Submissions Gateway (ESG) to the agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND, NDA and BLA submissions, and builds upon a previous commitment to provide submission-ready CMC documentation for client biological drug substance projects, according to the company. Creation of this electronic new product filing path was spearheaded by Laureate's Regulatory Services Group, which has extensive experience generating eCTD documents and publishing regulatory submission in XML format.
Laureate's chief executive officer, Michael A. Griffith, said, "We believe the future of new drug development will rely on adoption of better, more cost-effective ways of doing business and the ESG is a perfect example. Being able to eliminate paper reports, batch records and submissions just makes sense, and apparently the FDA agrees. Now, we will be able to provide clients with submission-ready CMC documentation and offer a path for submission to the FDA. If that is not a first in the industry it certainly underscores our commitment to provide each client with the best possible value for their CMC dollar."