Custopharm has partnered with McSnyder Software and developed a novel eCTD submission application software named Aspire eCTD. Through this partnership we have leveraged Custopharm's extensive experience with eCTD submissions and McSnyder's extensive expertise in software development.  The synergy between the two organizations have allowed the development of a software package that is usable from both an IT and user perspective. 

About Aspire 

Aspire eCTD is a windows application written in .NET that assists users in constructing electronic pharmaceutical submissions. Early on we spent a lot of time focusing on the user interface for Aspire eCTD to make it as simple as possible while maintaining the flexibility and power in many of the complicated document management features associated with the FDA approval process.

To learn more about Aspire's products please visit www.aspireectd.com. 

 Aspire eCTD Features

• User Friendly Interface - A True Visual Designer, not an XML Editor

• Visual Submission History - The Submission History shows clearly how documents have changed over the lifetime

• Validator Redirects to the Exact Error - Error messages allow the user to jump back to the offending document so you can make the necessary changes

• Internal Review and Approve - Each document can be approved or rejected when the submission is in a Review Status

• Multi-User - Multiple users can be given role specific access to applications in your library and perform only the functions they need too

• PDF Enhancements - Change a PDF to a particular version for compliance, check for broken links and edit PDF Meta-Data

• Import Published Submissions - You can import submissions that have been created in other software into Aspire eCTD

• Drug Studies - Manage Drug Studies and Study Tagging Data

Custopharm has partnered with SLS (State Licensing Services), a leading State Licensing Company that applies for licenses to sell pharmaceuticals in all 50 states.  SLS also manages the maintenance of the licenses for generic pharmaceutical companies. 

CustoPharm has partnered with Digital Certificate provider GlobalSign to assist customers in obtaining digital certificates for electronic submissions using the FDA Electronic Gateway (ESG). All submissions sent using the FDA ESG must be digitally signed using a digital Certificate. GlobalSign is an industry leader in providing publically trusted digital certificates and has issued over 300 digital certificates for the use of the FDA ESG since June 2009.

About GlobalSign

GlobalSign is a well established Certificate Authority and leading digital signature solution provider, including digital signature solutions for the FDA-regulated marketplace allowing clients to submit electronic records to the FDA, reducing submission time and cost. To learn more about GlobalSign's product please visit www.globalsign.com.

Custopharm has partnered with McSnyder Software to develop a novel eCTD submission application software. Through this partnership we will leverage Custopharm's extensive experience with eCTD submissions and McSnyder's extensive expertise in software development.  We believe the synergy between the two organizations will allow the development of a software package that is usable from both an IT and user perspective. 

About McSnyder 

McSnyder is a small software development company specializing in both the Apple and Windows platforms.To learn more about McSnyder's product development please visit www.mcsnyder.com.