THinc . . .  a REGULATORY AFFAIRS DEPARTMENT

For clients who need regulatory affairs support, we can help you strategize, formulate, and develop solutions to regulatory issues and prepare and process submissions that are compliant with regulatory guidelines.

Operations

THinc staff are driven to complete high-quality submissions that are compliant with regulatory guidelines and prepared within client-specified timelines. THinc’s expertise includes

  • File maintenance:  Set up, submit, and maintain regulatory files (e.g., IND, Clinical Trial Authorisation [CTA], and NDA files)
  • Document management:  Track, store, and retrieve regulatory documents using our proprietary document management system
  • Document production:
    • Format documents for paper or electronic submissions in accordance with ICH and the US Food and Drug Administration (FDA) requirements
    • Process individual documents for paper or electronic submission (e.g., eCTD format, including creation of pdf files, bookmarking, and hyperlinking)
    • Provide graphic support by designing, drawing, or modifying graphs or illustrations on an as-needed basis
THinc