AGI.do

Processes

What will AGI do for Compile and submit dossier?

A new product profile is finalized and regulatory submission planning is initiated for a drug or medical device.

Trigger
A new product profile is finalized and regulatory submission planning is initiated for a drug or medical device.
Outcome
The standardized registration dossier is fully assembled, reviewed, and submitted to the appropriate regulatory authorities for approval.

The work itself

Grounded Work Profile

Measured by

  • Dossier Compilation Cycle TimeprocessProfile
  • First-Pass Acceptance RateprocessProfile
  • Submission Error RateprocessProfile
  • Time To Regulatory ApprovalprocessProfile

Key steps

  • Define regulatory strategy and plan dossier structureprocessProfile
  • Create standard backbone and component templatesprocessProfile
  • Gather and author clinical, non-clinical, and CMC componentsprocessProfile
  • Standardize documentation metadata and formattingprocessProfile
  • Review submission components for regulatory complianceprocessProfile
  • Assemble and track dossier components against the submission planprocessProfile
  • Transmit the compiled dossier to regulatory authoritiesprocessProfile

How AGI delivers it

Four ways AGI delivers for Compile and submit dossier

  • Services-as-Software

    Get the professional outcome delivered as software, priced on results, not headcount.

    Services.do

  • Autonomous Agents as digital employees

    Hire a digital employee that does the job under earned, supervised autonomy.

    Agents.do

  • Business-as-Code

    Encode how your work runs, once, as software that executes itself.

    Platform.do

Value flow

How Compile and submit dossier connects

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