Compliance

Global Compliance

Compliance is not a box we tick — it is the mechanism through which we bring new medicines to Afghanistan legally and sustainably. Every step of our drug discovery and registration process is designed around international regulatory standards.

WHO Prequalification Standards

Our manufacturing partners meet WHO prequalification criteria — the global benchmark for quality, safety, and efficacy in pharmaceutical production. WHO-prequalified medicines are accepted by major procurement agencies including UNICEF and the Global Fund.

AFDA Registration Compliance

All products deployed in Afghanistan are registered with the Afghan Food and Drug Authority. We do not operate in grey-market importation. Every molecule undergoes the full AFDA dossier process — product details, GMP certification, clinical data, quality data, and Afghan-language labelling.

ICH Guidelines

Our quality and regulatory processes align with the International Council for Harmonisation (ICH) technical guidelines on safety (S), efficacy (E), and quality (Q) — the globally accepted standards for pharmaceutical development and registration.

Anti-Counterfeit & Traceability

Batch-level traceability is maintained from manufacturer to dispensing point. Blockchain-verified supply chain records provide an immutable audit trail, ensuring every unit in the Afghan healthcare network is authenticated and within its stability window.

Our Compliance Commitment

100%
AFDA-Registered Products
No grey-market operations
WHO-GMP
Manufacturer Standard
All partner facilities certified
Phase 3
Clinical Evidence Base
Publicly available trial data for all pipeline molecules