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Pharmaceutical Product Life Cycle Solutions

  

At ThinSpring, we understand that compliance activities do not exist in a vacuum and that they can substantially impact your company's core business processes. To help your company meet these challenges ThinSpring solutions combine the best of On-Demand software, Software as a Service (SaaS), and Outsourced services.

United States Food and Drug Administration (FDA) Drug Registrations, Listings and Content of Labeling

  • National Drug Code (NDC) Labeler Code Requests
  • FDA Drug Manufacturing Establishment Registrations
  • Prescription Drug Pre-Approval Content of Labeling Submissions
  • Prescription Drug Listing Submissions
  • Blood Products - Plasma Derivitives Listing Submissions
  • Vaccine Product Listing Submissions
  • Cellular Therapy Product Listing Submissions
  • Over-the-Counter Drug Listing Submissions
  • Animal Health Drug Feed Listing Submissions
  • Homeopathic Drug Listing Submissions
  • Bulk and Drugs for Further Processing Listing Submissions
  • European Medicines Agency (EMA) Pharmacovigilance (PV)
  • eXtended EudraVigilance Product Report Messaging (XEVPRM)
  • Medical Dictionary and Translation Term Management
  • Auditing and Life Cycle Management
  • Global Registration and Submission Tracking
  • Product and Submission Lifecycle Management
  • Corrective and Preventive Action Tracking and Management
  • Electronic Adverse Event, Individual Case Safety Reporting
  • Business Continuity Management

Offering a complete collaborative service environment, ThinSpring delivers a powerful, interactive solution set.

 

 

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