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Before you file · Before you pay MCAZ

Dossier gap review

We check your dossier against MCAZ’s screening checklist before anything is filed, so it passes first time.

Which regulator is the dossier for?
MCAZ doesn’t give second chances.
  • A dossier that fails screening gets one paid resubmission.
  • A second failure is refused without assessment.
  • No deadline extensions are granted.
Sources: MCAZ; 150 of 579 generic applications MCAZ finalised in 2018–2020 were refused (study).

What we check

CompletenessEvery item on MCAZ’s screening checklist (EVRF 30) present, signed, dated and in the right format, including the Word files MCAZ asks for.
Zimbabwe-specific itemsMC8 form, cover letter naming your local representative, labels and leaflet, GMP certificates for every site, and samples.
Scientific adequacyBioequivalence, stability for climatic zone IV, active-ingredient documentation and process validation, checked by a regulatory reviewer.

What you receive

Red, amber or green per sectionModules 1 to 5, rated against what MCAZ screens for.
A list of fixesExactly what to add or correct, most serious first.
Your pathway confirmedWhether the dossier holds the evidence for the route you want.

How it works

  1. 1Upload your dossierModules 1 to 5, as files or one ZIP. About 5 minutes.
  2. 2Get your quoteWithin one business day, based on the size of the dossier.
  3. 3We review itOur software and team check every screening item; a regulatory reviewer checks the science.
  4. 4Receive your reportUsually in about 5 working days, online and printable.

Confidential. Your dossier is stored privately and never shared.

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