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Regulatory affairs.
Submissions, labels and health authority questions.

Every submission, variation and label change as a record with its markets, owners, documents and next milestone. Auctal tracks guidance changes, drafts responses to health authority questions from your approved sources, and chases every sign-off.

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Northwind Therapeutics/Regulatory affairs

Submissions by market

Submissions · Zentrava9 All markets
  • US · sNDA, new indicationNext: FDA response, 18 NovOn track
  • EU · Type II variationNext: answer by 21 OctAt risk
  • UK · label updateNext: MHRA decisionSubmitted
  • Canada · new strengthNext: dossier lock, 4 NovDrafting
Sam reminded: EU answer due in 14 days

What it looks like
here.

01

Submissions by market

Every filing with its markets, owner, documents and next milestone, one view across the portfolio.

Submissions · Zentrava9 All markets
  • US · sNDA, new indicationNext: FDA response, 18 NovOn track
  • EU · Type II variationNext: answer by 21 OctAt risk
  • UK · label updateNext: MHRA decisionSubmitted
  • Canada · new strengthNext: dossier lock, 4 NovDrafting
Sam reminded: EU answer due in 14 days
02

Health authority questions

Each question logged, owned and answered from approved sources, with the clock on it.

HA questions7 open EMA
  • Q4: hepatic impairment exposure dataAnswer drafted from CSR section 11Due in 6d
  • Q2: stability at 30°CAnswered from module 3Answered
  • Q7: paediatric planWaiting on clinicalDue in 12d
Draft answer ready, every statement sourced
03

Guidance watch

FDA, EMA and MHRA updates matched to the products they touch, every morning.

Guidance · this morning3 new
  • EMA: revised guideline on hepatic impairment studies06:02Touches: Zentrava EU variation
  • FDA: draft guidance on oncology dose optimisation05:40Touches: ZEN-301
  • MHRA: updated labelling format05:15Touches: UK label update
Matched to 3 products, owners notified
04

Label changes, tracked

Who changed what, why, and which materials now need updating.

Label change · v8Zentrava
  • Section 8.6, hepatic impairmentChanged by Hannah Lee · 12 SepApproved
  • Materials to updateCore deck, 2 leave-behinds, SR-1144 items
  • Field teams toldCommercial and medicalDone
Update requests sent to the 4 material owners

Ask Auctal.
In your function's own words.

  1. 1“Which Zentrava submissions have a health authority question open?”
  2. 2“Draft it from the approved clinical overview.”
Northwind Therapeutics
Northwind Therapeutics/Auctal/Regulatory affairs
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