Solutions for Biologics Manufacturers

At Thinspring, we understand that compliance activities do not exist in a vacuum and that gaps in Regulatory Information Management (RIM) can substantially impact your company's core business processes. To help your company meet these challenges ThinSpring solutions combine the best of Structured Content Authoring (SCA) and Software as a Service (SaaS) technology to provide flexible and responsive electronic submissions solutions.

United States Food and Drug Administration (FDA) - Structured Product Labeling (SPL)

• National Drug Code (NDC) Labeler Code Requests
• FDA Drug Manufacturing Establishment Registrations
• Identification of CBER-Regulated Generic Drug Facility Submissions
• Human Cell and Tissue Establishment Registration & Product Listing
• Human Cell and Tissue Establishment Registration & Product Listing Change
• Physicians Labeling Rule PLR Content of Labeling (CoL) Submissions
• Prescription Drug Listing Submissions
• License Blood Intermediates/Paste Label
• Licensed Minimally Manipulated Cells Label
• Licensed Vaccine Bulk Intermediate Label
• Standardized Allergenic Label
• Non-Standardized Allergenic Label
• Plasma Derivative Listing Submissions
• Recombinant Deoxyribonucleic Acid Construct Label
• Vaccine Label and Listing Submissions
• Lot Distribution Data (LDD) electronic Lot Distribution Reports (eLDR)
• Blanket No Change Annual Listing Certifications
• Bulk and Drugs for Further Processing Listing Submissions
• Risk Evaluation & Mitigation Strategies
  • REMS Release
  • REMS Conversion to Shared Systems
• Drug Indexing
  • Billing Unit
  • Biologic or Drug Substance
  • Indication
  • Pharmacologic Class
  • Product Concept
  • Risk Evaluation & Mitigation Strategies
  • Substance
  • Warning Letter Alert

FDA and European Union (EU) Electronic Common Technical Document Submissions (eCTD)

• Biologics License Application (BLA)
  • Original BLA
  • BLA Amendment
  • BLA Supplement
  • Annual Report
  • ADPromo to CBER FDA Advertising and Promotional Labeling Branch (APLB)
  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Adverse Experience Report (PAER)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Rolling Submissions (Rolling Review)
  • Grouped Submissions

Other Predicate Rule Required Submissions

• Affordable Care Act Drug Sample Submissions (ACA 6004)
• Individual Case Study Report (ICSR) Drug Safety Report Submissions

Other Services

• Medical Dictionary and Translation Term Management
• Auditing and Life Cycle Management
• Global Registration and Submission Tracking
• Product and Submission Lifecycle Management
• Structured Content Authoring Environment Development
• Computer System Validation

Offering an end to end collaborative service environment for submissions management, ThinSpring delivers a powerful, interactive solution set.