Datafarm Introduces Complete, Affordable, eSubmission Packages for Small to Medium-Sized Businesses
2008-09-22 23:59:02 -
- A leading provider of Electronic Document Publishing solutions and Regulatory Submissions Services for the Life Sciences Industry, Datafarm is pleased to announce newly created electronic submission packages, "eStarter" and "eAdvanced", for small to medium-sized businesses that need a solution implemented quickly and cost effectively.
Datafarm's S-Cubed(R) eSubmission solution is used by many Life Sciences companies to create, validate, publish, and submit their regulatory submissions. For small companies such a comprehensive, compliant and proven solution has often been perceived as being too complex, too expensive and too reliant on additional hardware and eDMS applications. As Shy Kumar, CEO and President of Datafarm responds, "...this is no longer the case. We have created packages for small and medium size life sciences businesses that offer everything they need to establish a successful, compliant, electronic submission processing environment for a very competitive price."
The eStarter and eAdvance packages are designed to provide everything needed to create a compliant electronic submission. The package includes:
-- Templates - Includes CTD, CTA, IND document templates based on ICH and regional agency requirements
-- a-Pulse(R) - Acrobat plug-ins to automate the PDF publishing process
-- S-Cubed(R) - comprehensive eCTD and NeES publishing, compilation, review, validation, and lifecycle management capabilities
-- Paper Dossier - to create Paper dossier from electronic (eAdvanced only)
-- eCTDGatekeeper - stand-alone validation tool for secondary validation
-- Deployment - Onsite installation and validation services
If you would like to know more about Datafarm's entry packages please contact Maria Fabbo, +1 (508)624-6454, or email info@datafarminc.com.
Datafarm, Inc.: Established in 1997, Datafarm is a leading provider of Electronic Document Publishing solutions and Regulatory Submissions Services for the Life Sciences Industry. Datafarm augments the drug development process by providing custom and off-the-shelf solutions worldwide, producing high-quality, and agency-compliant e-Submission-ready documents. Headquartered in Marlborough, Massachusetts, USA, Datafarm has regional offices in California, the UK, France, and India. To date, the company's products have been utilized in compiling thousands of eSubmissions. Our Regulatory Services Group has joined forces with sponsors to submit hundreds of eCTD dossiers to the FDA, Health Canada, EMEA, and Japanese regulatory authorities.
Datafarm
USA
Maria Fabbo, +1 508-624-6454
maria.fabbo@datafarminc.com
or
Europe
Paul Herd, +44 (0) 870 774 4298
paul.herd@datafarminc.com
or
India
Veeresh Sondur, +91 080 329 03619
veeresh@datafarminc.com