Regulatory and validation

Regulatory impact and submissions

Screen a change for regulatory impact with a suggested reporting route per market, confirm each route as regulatory affairs, then draft submission sections in which every claim is sourced to a document and verified.

In the portal: /app/submissions

The submission procedure

Regulatory impact screening
  1. Person

    1. Describe the change

    Type, markets, change record attached

  2. AI drafts

    2. Assess regulatory impact

    Registered details affected, route per market

  3. Person

    3. Decide each route

    RA confirms or changes the category

  4. AI drafts

    4. Draft sections

    Every fact cites a source

  5. Person

    5. Verify claims

    Each claim verified or rejected

  6. Person

    6. Approve sections

  7. Person

    7. Record the decision

  8. E-signature

    8. Review and approval

  • The filing itself is made in your regulatory system; this record documents the assessment, the sources and the decision.

Screen a change

  1. Step 1: Open Regulatory submissions and choose New change.
  2. Step 2: Choose the Type of change, give the change control reference, title and product.
  3. Step 3: Tick the Markets where the product is registered: United States (FDA), European Union, United Kingdom (MHRA), Canada, Japan or other.
  4. Step 4: Paste the change description, or attach the change control record, with impact assessments, specifications, validation reports, comparability or stability data and the registered dossier extract.
  5. Step 5: Keep Assess the regulatory impact now ticked and choose Create and assess.

Impact and reporting routes

The assessment states what changes, the registered details affected (CTD section, detail, effect, quote), a supporting-data checklist (provided, incomplete, missing), questions for regulatory affairs and an impact classification: prior approval likely, notification likely sufficient, likely no filing, or cannot determine.

MarketCategories the AI considers
United StatesPrior Approval Supplement, CBE-30, CBE-0, Annual Report
EU and UKType IA, Type IAIN, Type IB, Type II variation
CanadaLevel I Supplement, Level II Notifiable Change, Level III Annual Notification, Level IV
JapanPartial change approval or minor change notification

For each market choose the RA decision (with a reason): Suggested route confirmed, Different category (enter it), or No filing in this market.

Sourced sections and the decision

  • Draft section (AI): description of the change, justification, impact on quality, safety and efficacy, summary of supporting data, comparability, or cover letter (up to 12).
  • Each fact carries a marker [C1] with the exact quote from its source; unsupported points are listed as not sourced.
  • Open each claim and choose Verified or Rejected. Approve section (RA) needs every claim verified; approved sections cannot be edited. Set aside: not used with a reason.
  • Record the decision: Proceed to submission (needs at least one approved section), No filing required: document in the change record, or More data needed before deciding.