Navigation Links
Laureate's Electronic Submission Gateway Approved
Date:6/24/2011

PRINCETON, N.J., June 24, 2011 /PRNewswire/ -- Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND (Investigational New Drug), NDA (New Drug Application) and BLA (Biologic License Application) submissions and builds upon a previous commitment to provide submission-ready CMC (Chemistry, Manufacturing and Control) documentation for client biological drug substance projects. Creation of this electronic, new product filing path, was spearheaded by the Regulatory Services Group, who have extensive experience generating eCTD documents and publishing regulatory submission in XML format.

Commenting on this development Laureate's CEO, 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." Continuing on he said, "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."

Robert Burford, Ph.D., Vice President Regulatory Services said, "Besides publishing and submission services, Laureate will offer a wide range of regulatory support activities to its clients including high level consulting services for regulatory strategy, IND completion, report generation and regulatory submission reviews." Continuing he said, "When a client chooses Laureate as its contract manufacturing organization, it gets a committed partner capable and ready to see a project through to submission."

About Laureate Biopharmaceutical Services, Inc.

Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization. Laureate Biopharma's scientists are expert in process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company's portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate Biopharma has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC.  For more information, please visit www.LBioS.com.

About Saints Capital, LLC

Saints Capital is a leading direct secondary acquirer of venture capital and private equity investments in emerging growth companies around the globe. It also makes traditional direct venture capital investments on a primary basis and in special situations in technology, healthcare, consumer and industrial companies in the United States. Founded in 2000, Saints provides liquidity for private investors in such markets as investment and commercial banks, buyouts, corporate venture capital and hedge funds. Saints has more than $1 billion of committed capital under management, over 50 completed portfolio transactions and investments in more than 200 companies. For more information, please visit www.saintsvc.com.

For more information, contact: Robert Burford, Ph.D., Vice President, Regulatory Services Group, Laureate Biopharmaceutical Services Inc., at (609) 919-3332, or email Robert.Burford@LbioS.com, or visit www.LBioS.com.


'/>"/>
SOURCE Laureate Biopharmaceutical Services, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Elsevier Celebrates Nine 2010 Nobel Laureates and Honors Achievements With Freely Available Prize-Winning Research
2. Thomson Reuters Predicts Nobel Laureates
3. Aspire Indiana Works with MedInformatix to Customize Practice Management and Electronic Medical Records Solution for Psychiatric Practices
4. CHPA Applauds Electronic Stop-Sale Technology Becoming Law in Texas
5. CHPA Hails Passage of Electronic Stop-Sale Technology by the NC Legislature
6. Benchmark Electronics Recognized as Supplier for 2011 Design Medical Excellence Award Winner in the Radiological and Electromechanical Devices Category
7. Benchmark Electronics Recognized as Supplier for 2011 Design Medical Excellence Award Winner
8. Elekta to Feature Certified MOSAIQ EHR at Electronic Health Records Lab During the 2011 ASCO Annual Meeting
9. CVS Caremark to Pilot Electronic Prior Authorization to Help Speed Patient Access to Prescription Medication
10. STMicroelectronics Reveals Best-in-Class Technology Enabling Longer-Lasting Broadcast and Medical-Imaging Equipment
11. Governor Daniels Signs Into Law Electronic Tracking Bill
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... Oct. 10, 2017   West Pharmaceutical Services, Inc. ... for injectable drug administration, today shared the results of ... for improving the intradermal administration of polio vaccines. The ... Summit in May 2017 by Dr. Ondrej Mach ... World Health Organization (WHO), and recently published in the ...
(Date:10/5/2017)... ROSEMONT, Ill. , Oct. 5, 2017 /PRNewswire-USNewswire/ ... American Association of Oral and Maxillofacial Surgeons (AAOMS) ... than opioids – to be used as a ... post-surgical pain. ... relationship, the AAOMS White Paper "Opioid Prescribing: Acute ...
(Date:10/4/2017)... to the Centers for Disease Control and Prevention (CDC), influenza vaccination ... is helping communities across Massachusetts , Connecticut ... flu shots through the end of the month. *Some exclusions ... ... shot is by the end of October, according to the Centers for ...
Breaking Medicine Technology:
(Date:10/12/2017)... , ... October 12, 2017 , ... Leading pediatric oncology ... in Washington, D.C., for the 49th Congress of the International Society of Paediatric ... President of the Center for Cancer and Blood Disorders at Children’s National, ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... named one of Michigan’s 2017 Best and Brightest in Wellness® by Best and ... Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... $3,296 in property taxes a year. In some states—like New York, New Jersey, ... By contrast, many overseas retirement havens have extremely low property-tax rates, which contributes ...
(Date:10/12/2017)... ... 2017 , ... Farm Forward joins Bon Appétit ... institutions in announcing the launch of the Leadership Circle , a program ... raised for food. , Founding members of the Leadership Circle also include Airbnb’s ...
(Date:10/12/2017)... ... October 12, 2017 , ... Nvision ... executive staff with the addition of industry sales leader, Thomas (Tom) Slott, as ... the national distribution and sales network, direct the efforts of the surgical sales ...
Breaking Medicine News(10 mins):