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:5/5/2016)... ... May 05, 2016 , ... Phycologia ... A (UV-A) for photosynthesis, researchers Juntian Xu and Kunshan Gao tested the magnitude ... pair observed that when photosynthetically active radiation (i.e. the white light in our ...
(Date:5/5/2016)... ... 05, 2016 , ... Derrin Doty Group has unveiled the latest charity campaign ... communities west of Seattle. The insurance provider’s caring team has been so moved by ... due to complications from the flu, that they have decided to extend their original ...
(Date:5/5/2016)... ... May 05, 2016 , ... The University of ... to host the 2016 National SACA Leadership Conference on the Portland campus September ... chapter officers to come together and develop skills to be future leaders in ...
(Date:5/5/2016)... , ... May 05, 2016 , ... Vitenas Cosmetic Surgery ... Design Awards, presented by the American Institute of Architects and the Academy of Architecture ... the renowned Perkins+Will and Harrell Architects, opened to patients in October of 2014. ...
(Date:5/5/2016)... ... , ... Dr. Benjamin Stong of Kalos Facial Plastic Surgery, LLC in Atlanta, ... double board certified and the only facial plastic surgeon in Atlanta to offer ... such as stem cells can be used to provide stabilization to hair transplant results ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... According to market research "Global ... and Demand Forecast to 2022 - Industry Insights by ... Very High Field, Low to Mid Field, and Ultra ... Musculoskeletal, Vascular, Breast, Pelvic and Abdomen, Cardiac, and Other)" ... market was valued at $5,351.7 million in 2015, and ...
(Date:5/3/2016)... , May 3, 2016 Intec ... a clinical-stage biopharmaceutical company, today announced the appointment of ... Regulatory Affairs. "Ms. Strauss-Levy has 15 years ... has established an outstanding track record, having supported the ... regulatory approval processes in the United States ...
(Date:5/3/2016)... Global and Chinese Surgical ... overview of the industry that covers definition, applications ... report explores into the international and Chinese players ... Surgical Mesh market spread across 150 pages providing ... is available at http://www.reportsnreports.com/reports/470569-global-and-chinese-surgical-mesh-industry-2016-market-research-report.html . ...
Breaking Medicine Technology: