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Submissions Assurance™ Consulting

TAKE Solutions’ Submissions Assurance™ Programs offers two uniquely targeted Submission Assurance delivery models. One Submissions Assurance™ offering will be available to TAKE Solutions’ customers that license TAKE Solutions’ PharmaReady™ eCTD software solution. A separate Submissions Assurance™ delivery model is available to customers that want to fully outsource this service without the requirement of licensing any software. In this instance, TAKE Solutions’ submission services group will utilize its PharmaReady™ eCTD software solution, internally, as part of a fully outsourced solution.

The FDA mandate for regulated life sciences organizations to submit IND’s and NDA’s electronically, is requiring these fast-moving organizations to seek assistance from trusted partners. Now adding to this, EMEA requirements for electronic submissions beginning in 2009, has created even greater demand for our Submission Assurance™ services.

Submissions Assurance™ key deliverables include but are not limited to the following:

• Develop Submission Roadmaps & Project Plans
• Ensure Agency Specific Document Formatting
  and Publishing
• Develop CTD Structuring and Document
  Content Plan
• Provide Submission Compilation and
  Life Cycle Management
• Support and Manage Pilot Submissions
• Perform as Regulatory Agency Liaison

Click here to request a no obligation consultation to determine the scope of your Submission Assurance project.

• Overview
• Validation Services
• Regulatory Consulting Services
• Implementation Services
• Technical Support
• Education
• eCTD Templates
• PharmaReady Hosting