Auditable by design
Every submission rests on an ALCOA+ documented trail, built to satisfy the receiving authority.
A product is only a candidate until an authority approves it. Eknox compiles, submits and maintains market-authorization dossiers across diverse regulatory systems — built on rigorous evidence and a close reading of each authority's expectations.
We measure the product and its dossier against each target authority's requirements.
We assemble or remediate the CTD dossier — quality, safety, efficacy and administrative evidence.
We submit and manage queries, deficiencies and timelines through to decision.
On approval, we coordinate importation, distribution and market entry.
We manage renewals, variations and pharmacovigilance for the life of the product.
One body of evidence, many markets — assembled so a product can move from one jurisdiction to the next without rebuilding its case 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 to, liaise with, and maintain authorizations across national medicines authorities and continental frameworks — meeting each on its own terms.
We are engaged across 19 nations in Africa and three in South America, working with their respective medicines authorities, and the model is built to extend to new markets. If a target market is not yet in the network, we assess feasibility and build the pathway.
Yes. We tailor the route — medicine, supplement, botanical, natural product or device — to each product's classification in each market.
We 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 pathway to approval.