PRODUCTS:

Document Templates and Tools:

•  Regulatory document templates (labeling, correspondence, forms)

•  Clinical and Nonclinical document templates

•  eCTD document templates

•  Customized toolbars for easy and consistent application of styles

•  Customized master templates designed around corporate style guide

SERVICES:

Providing Proven Expertise in:

•  Electronic Common Technical Document (eCTD)

•  Document Templates and Template Development

•  Electronic Document Management Systems (EDMS)

•  Desktop and Submission Publishing

•  Submission Process Development –

•  Electronic and Paper Submissions

•  Investigational and Marketing Applications

•  Review and Approval

•  Standard Operating Procedures

•  System Selection, Implementation, and Management

•  Computer System Validation (IQ, OQ , PQ )