Enhancing Efficiency: AI-Driven Precision and Speed in Document Creation


Background: Regulatory documentation consumes substantial time and imposes significant costs

Documentation specialists are tasked with interpreting information provided by subject matter experts, which can often be prone to misinterpretation, resulting in document inaccuracies.

To counter this, the writer frequently conducts iterative exchanges with the expert(s). Pfizer reports taking up to 10 years for FDA approval, with regulatory documentation taking 6-12 months to generate and approve.

How much do companies currently spend on Regulatory Documentation?

  • Specialists typically take 3-5 days to develop a 2-10 page standard operating procedure (SOP).
    • e.g., ThermoFisher Q Exactive Plus Manual (258 pages, with
      around 30-35 SOPs)
    • 1 writer ($100/hr) = 3-6 months & $48K-$96K to write.
    • 1 product = 2-3 manuals (hardware manual, software manual, etc.)
  • KARDA streamlines this process and increases the efficiency of both
    documentation specialists and experts, resulting in significant cost savings and an accelerated time-to-market for your own products.