Navigation Links
Datafarm™ Announces HollisterStier Contract Manufacturing Regulatory Affairs Deploys S-Cubed eCTD
Date:9/30/2009

HollisterStier Contract Manufacturing installed and validated Datafarm's S-Cubed® eCTD to manage and compile electronic regulatory submissions for the FDA. This would include drug product information supplied by HollisterStier, along with the clients' submission-ready drug substance, clinical and non-clinical data.

Marlborough, MA (PRWEB) September 30, 2009 -- Datafarm™, a world leading provider of high performance electronic regulatory submission solutions for the life sciences industry, today announced that HollisterStier Contract Manufacturing installed and validated S-Cubed® eCTD to manage and compile electronic regulatory submissions for the FDA. This would include drug product information supplied by HollisterStier, along with the clients' submission ready drug substance, clinical and non-clinical data.

HollisterStier's Regulatory Affairs department adds this software to their existing electronic capability which includes assisting clients in the creation of an FDA Electronic Submission Gateway (ESG) account at client sites for direct submission of electronic information to the FDA. Additionally, HollisterStier can perform electronic establishment registration and electronic drug listing using Structured Product Labeling (SPL) eXtensible Markup Language (XML) functions for clients or train clients' staff to perform these functions. HollisterStier's electronic submission offerings provide a comprehensive set of regulatory support options under the same roof as fill/finish operations.

About S-Cubed eCTD
Datafarm's S-Cubed® eCTD includes all of the latest global regulatory agency requirements so that users can quickly create consistent and compliant eCTD submissions. S-Cubed eCTD enables complete lifecycle management of the eCTD allowing users to publish, compile, review, validate and track all content throughout the entire drug development process. S-Cubed® eCTD conforms to the current ICH and Regional requirements for delivering eCTD submissions to the US, EU, Canada, Japan, and Taiwan regulatory agencies. Click here for more information about S-Cubed eCTD.

About Datafarm Inc.
Established in 1997, Datafarm is a world leader in high performance electronic regulatory submission solutions for the life sciences industry. Datafarm's open, modular technologies and professional services experts enable life sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions. Headquartered in Marlborough, Massachusetts, US, Datafarm has regional offices in California in the US, UK, France, and India.

###

Read the full story at http://www.prweb.com/releases/2009/09/prweb2961414.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
2. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
3. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
4. HEI, Inc. Announces Sale of RFID Division Assets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
8. Brooke Franchise Corporation Announces Selected July Results
9. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
11. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Datafarm™ Announces HollisterStier Contract Manufacturing Regulatory Affairs Deploys S-Cubed eCTD
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: