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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.