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Regulatory Compliance

Compliant by design.
Trusted globally.

Ramso Healthcare products are manufactured and documented to meet the regulatory requirements of importing markets across Africa, South Asia, the Middle East and beyond.

Our compliance framework

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WHO-GMP Compliant Manufacturing
Our manufacturing partner operates under World Health Organisation Good Manufacturing Practices — the international standard accepted by regulatory authorities across Africa, South Asia, ASEAN, and the Middle East for pharmaceutical imports.
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CDSCO Drug Licence — Form 28
Licensed under the Drugs and Cosmetics Act, 1940 by India's Central Drugs Standard Control Organisation. This is the foundational licence required for legal pharmaceutical manufacture and export from India.
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ISO 9001:2015 Certified
Our Quality Management System is certified to ISO 9001:2015 — the international standard for consistent, customer-focused quality delivery across all processes from sourcing to shipment.
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BP / IP Pharmacopoeial Standards
All formulations are manufactured to British Pharmacopoeia (BP) and Indian Pharmacopoeia (IP) standards — pharmacopoeial grades accepted by regulatory authorities in regulated and semi-regulated markets worldwide.
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ICH Zone IVb Stability Testing
Products are stability-tested at 40°C/75% relative humidity per ICH Zone IVb guidelines — the standard for tropical and subtropical climates including Sub-Saharan Africa, South Asia, and Southeast Asia.
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cGMP Standards
Current Good Manufacturing Practice compliance ensures our manufacturing processes, documentation, and quality systems meet the evolving standards required for export to WHO prequalification-aligned markets.

Market-specific regulatory support

We provide complete regulatory dossiers tailored to your country's import registration requirements — including CPP, Free Sale Certificate, SmPC, stability data, MFR, and CoA. Our team assists distributors and importers through the documentation process for their local regulatory authority.

Ghana
Nigeria
Kenya
Nepal
UAE
Saudi Arabia
Tanzania
Myanmar
Sri Lanka
& more

Need regulatory support for your market?

Send us your target country and product requirements — we will advise on the documentation needed and prepare your registration dossier.

Send Regulatory Enquiry → WhatsApp Us