Regulated Product Submission / Clinical Data Management

Rushing to get a quality submission done?

Planning FDA regulated product submissions can be a significant undertaking. Virtify’s submissions consulting helps you succeed by unlocking the power of our business solutions and providing you with the greatest value from your investment.

Our experts provide the strategic guidance and hands-on expertise you need to make your FDA Submissions initiative a success. Regardless of whether you're creating your first Submission or addressing a unique issue, there's a services offering for your organization.

Regulated Product Submissions Support
 

a. Submissions Planning:

  • Resource planning
  • Submission Tools & Vendor Evaluation
  • Staff augmentation
  • Process improvement

b. Submissions Tracking:

  • Project Management
  • Status Monitoring
  • Workflow setup

c. Conversion Services:

  • SPL/PLR
  • eCTD
  • RPS
  • eStability

d. Assembly & Publishing:

  • Paper to Electronic
  • PDF Generation
  • eCTD to Paper

e. Quality Control:

  • Document Validation Checklist
  • Submission Validation Checklist
  • Proof-Reading
  • Word to Word Comparison

f. Transmission:

  • FDA Electronic Gateway
  • Secure Email
  • SAFE

g. Submission Archival:

  • Document Management System setup

CDISC Services

  • Legacy data Conversion to SDTM.
  • Annotation of Electronic CRF.
  • Creation of CDISC compatible databases
  • Data extraction and Mapping of study information
 

Next Steps