Solutions for Pharmaceutical 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 submissions solutions.

United States Food and Drug Administration (FDA) and Health Canada (HC) - Structured Product Labeling (SPL) and Structured Product Monograph (SPM)

• HC - Structured Product Monograph (SPM) Product Monograph Template
• FDA - National Drug Code (NDC) Labeler Code Requests
• FDA - Drug Manufacturing Establishment Registrations
• FDA - Wholesalers and Third-Party Logistics providers (3PLs) Registration (WDD/3PL)
• FDA - Generic Drug Facility GDUFA Self Identification Submissions
• FDA - Prescription Drug Pre-Approval Content of Labeling (CoL) Submissions
• FDA - Physicians Labeling Rule (PLR) Submissions
• FDA - Prescription Drug Listing Submissions
• FDA - Human Compounded Drug Listing Submissions
• FDA - Blanket No Change Annual Product Listing Certifications
• FDA - Over-the-Counter (OTC) Drug Listing Submissions
• FDA - Center for Veterinary Medicine (CVM) Animal Health Drug Master File (DMF) Submissions
• FDA - Center for Veterinary Medicine (CVM) Animal Health Product Listing Submissions
• FDA - Homeopathic Drug Listing Submissions
• FDA - Bulk Drug Product Listing Submissions
• FDA - Drugs for Further Processing Listing Submissions
• FDA - Risk Evaluation & Mitigation Strategies Submissions
  • REMS Release
  • REMS Conversion to Shared Systems
• FDA - 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)

• Drug Master File (DMF)
  • Original DMF
  • Annual Report
  • DMF Amendment
  • Letter of Authorization (Authorization or Withdrawal)
• Investigational New Drug (IND)
  • Pre-submission
  • Original IND
  • IND Amendment
  • IND Safety Reports
  • Annual Report
  • Rolling Submissions (Rolling Review)
  • Grouped Submissions
• New Drug Application (NDA)
  • Pre-submission
  • Original NDA
  • NDA Amendment
  • NDA Supplement
  • Annual Report
  • ADPromo to CDER FDA Office of Prescription Drug Promotion
  • 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
  • 505 B (2) - NDA
• Abbreviated New Drug Application (ANDA)
  • Original ANDA
  • ANDA Amendment
  • ANDA Supplement
  • Annual Report
  • ADPromo to CDER FDA Office of Prescription Drug Promotion (OPDP)
  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Adverse Experience Report (PAER)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Grouped Submissions

Other Predicate Rule Required FDA Submissions

• Individual Case Study Report (ICSR) Drug Safety Report Submissions
• Electronic Medical Device Reporting (eMDR) Submissions
• All regions Non-eCTD electronic Submissions (NeeS) formats including FDA eSubmitter

Other Services

• Import Detention Remediation and Resolution 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 and flexible set of services and tools.