Quality
How we hold
the line.
Compliance is not a marketing surface for us. It is the operational discipline that decides whether a customer trusts us with their next purchase order. The frameworks below describe what we pursue across our supplier and distribution network.
Compliance roadmap.
We align supplier qualification, GxP coordination, and regulatory documentation with the frameworks our partners require. Each of the standards below addresses a different segment of the supply chain.
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WHO-GMP
Good Manufacturing Practice
Supplier alignment with the World Health Organization's Good Manufacturing Practice guidelines — the baseline standard for pharmaceutical manufacturing across regulated and emerging markets.
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EU-GDP
Good Distribution Practice
European Union Good Distribution Practice for storage, handling, and transit. Governs how we (and our partners) keep medicines within their licensed conditions from manufacturer to destination.
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US FDA
Registered facility coordination
Supplier sourcing from US FDA-registered facilities for partners shipping into or referencing the United States market — including DMF coordination where applicable.
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ISO 9001:2015
Quality management system
An ISO 9001:2015-aligned quality management system as the organisational backbone for our intake, qualification, documentation, and dispatch processes.
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PIC/S
Pharmaceutical Inspection Co-operation Scheme
PIC/S-compliant supplier preferences for partners exporting into jurisdictions whose inspectorates are members of the Scheme.
The frameworks listed represent our compliance roadmap — the standards we pursue across our supplier and distribution network. Partner enquiries about specific certificates and audit history are welcome.
Supplier qualification.
Every supplier we onboard goes through a four-step qualification before we issue a single purchase order on a customer's behalf:
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01
Documentary review
Manufacturing licence, GMP certificate, regulatory approvals, quality manual, and recent inspection history.
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02
Technical assessment
Product specifications, methods of analysis, stability data, impurity profile, and process flow review.
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03
Sample & reference batch
Reference batch testing through an independent laboratory where customer specifications require it.
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04
Approval & listing
Supplier added to the qualified network; periodic re-qualification at intervals defined by category and risk profile.
Cold-chain integrity.
Temperature-sensitive products are coordinated end-to-end against the appropriate temperature class: ultra-cold biologics at −80°C, frozen vaccines and plasma at −25°C, refrigerated insulins and biologics at 2–8°C, controlled room temperature solid orals at 15–25°C, and ambient OTC and devices.
Where partner specifications require it, shipments carry temperature loggers with arrival download and excursion review against the licensed conditions.
Document trail.
Every transaction produces a packet you can audit: certificates of analysis at lot level, regulatory documentation aligned to the destination market, chain-of-custody records, and shipment evidence including temperature logger downloads where applicable.