Auditable by design
Every submission rests on an ALCOA+ documented trail built to satisfy the receiving authority.
Eknox compiles, submits and maintains market-authorization dossiers across African and South-American regulators — built on ICH science and deep local regulatory intelligence.
We review the product and dossier against each target authority's requirements.
We assemble or remediate the CTD dossier — quality, safety, efficacy and administrative modules.
We submit to the national authority and manage queries, deficiencies and timelines.
On approval, we coordinate importation, distribution and launch.
We manage renewals, variations and pharmacovigilance for the life of the product.
One harmonized quality case, many markets — so a manufacturer's product can move jurisdiction to jurisdiction without rebuilding its evidence each time.
Every submission rests on an ALCOA+ documented trail built to satisfy the receiving authority.
Regional administrative and prescribing information for each authority.
Chemistry, manufacturing and controls — the quality backbone of the dossier.
Non-clinical study reports supporting the safety profile.
Clinical study reports supporting efficacy and use.
We submit, liaise and maintain authorizations with national medicines regulatory authorities across our markets — including continental and WHO frameworks.
We are actively engaged across 19 African nations and three South-American markets, working with their respective national medicines regulatory authorities. If your target market is not listed, we can assess feasibility and build the pathway.
Yes. We tailor the regulatory route — medicine, supplement, botanical, natural product or device — to each product's classification in each market.
We can assemble new CTD dossiers or remediate and re-strategize existing ones to meet a specific authority's expectations.
Every engagement is governed by FCPA, UK Bribery Act and OFAC sanctions controls, documented due diligence and ALCOA+ data integrity.
Send your product and target markets — we will map the regulatory pathway.