Market Authorization & Regulatory Affairs
The fastest compliant route to registration across Africa
Your product can't earn a cent until it's registered. We make that happen — sooner, and with fewer surprises.
What we do
How this service works
Registration is the single biggest barrier between your product and African patients. In most markets it takes 12–36 months, and the majority of that time is lost not to science but to avoidable deficiencies, the wrong submission pathway, and uncoordinated country-by-country filings. ProReg Africa turns that backlog into approvals.
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01
Regulatory strategy & country prioritization
which markets first, which pathway in each, and the sequence that gets you to revenue fastest
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02
Pathway selection
full assessment, abridged/reliance, or collaborative procedures, chosen per product and per market
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03
Dossier compilation & gap analysis
CTD/eCTD/ACTD structuring, CMC and labelling review, and a pre-submission screen against each NRA's real expectations
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04
Submission & query management
filing to national regulatory authorities and managing deficiency rounds to closure
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05
Reliance & recognition
leveraging WHO Prequalification, WLA/SRA approvals, WHO CRP, ZaZiBoNa, and regional harmonization to compress timelines
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06
Variations, renewals & lifecycle maintenance
keeping every licence current and in force
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07
Local representation
acting as your in-country agent or Marketing Authorization Holder where the market requires one
Ready to move on Market Authorization & Regulatory Affairs?
Tell us your product and target markets — we'll map the fastest compliant path.