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:1/20/2017)... ... 2017 , ... "TransFlare 4K Mystique comes with 44 colorful mysterious transitions that ... Christina Austin - CEO of Pixel Film Studios. , TransFlare 4K Mystique contains ... lens flare and light leak transitions have a very high-dynamic range for super smooth ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a ... has set out for each of his children. “The Angel” is the creation of ... Music in New York City, and impassioned writer. , When asked of her new ...
(Date:1/20/2017)... ... January 20, 2017 , ... D R Burton Healthcare Products ... was featured in a study indicating superior performance against competitive products in secretion ... Three Oscillating Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the ...
(Date:1/20/2017)... ... 2017 , ... “Knowledge is God’s Lighthouse”: a moving and colorful collection ... is the creation of published author, Gene Gaapf, a retired truck driver, and a ... have been writing since high school and have many different titles,” Gaapf mentions about ...
(Date:1/19/2017)... ... 2017 , ... Today, the Centers for Medicare & Medicaid Services (CMS) announced ... Models (APMs) in 2017. Clinicians who participate in APMs are paid for the quality ... the Administration’s effort to build a system that delivers better care and one in ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , Jan. 19, 2017  Abaxis, Inc. (NasdaqGS: ... point-of-care blood analysis instruments and consumables for the medical ... to discuss its financial results for the third quarter ... will be at 4:15 p.m. ET on Thursday, January ... the third quarter fiscal year 2017 after the market ...
(Date:1/19/2017)... , Jan. 19, 2017  Sensus Healthcare, ... device company specializing in the treatment of non-melanoma ... keloids, with superficial radiation therapy, today announced that ... year 2016 financial results on Thursday, February 2, 2017 ... will hold a conference call with the investment ...
(Date:1/19/2017)... Shire plc (LSE: SHP, NASDAQ: ... and Drug Administration (FDA) has acknowledged receipt of the ... for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. ... for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to ... the designated Prescription Drug User Fee Act (PDUFA) action ...
Breaking Medicine Technology: