Quality & compliance

Good Distribution Practice principles applied to every product, document and shipment.

Quality & compliance

Our quality framework

Quality is a process, not a promise

Pharmaceutical products are only as good as the supply chain that delivers them. Our quality framework is built on the principles of Good Distribution Practice (GDP) as described by the World Health Organization and the European Union, adapted to the realities of cross-border trade.

From the qualification of a new supplier to the handover of temperature records at delivery, every step is documented, owned and reviewed.

Six pillars of our quality system

Supplier qualification

GMP certificates, regulatory history and audit reports reviewed before the first purchase; periodic re-qualification thereafter.

Customer qualification

We supply only licensed importers, wholesalers and healthcare institutions, and verify licences before shipment.

Documentation & traceability

Batch-level documentation and records linking every unit from manufacturer to customer.

Storage & transport control

Temperature-mapped storage and validated transport packaging with continuous monitoring.

Deviation & recall management

Written procedures for deviations, complaints, returns, falsified-product suspicion and recalls.

Training & improvement

Staff trained in GDP principles; processes reviewed and improved through regular self-inspection.

Temperature integrity from origin to destination

Cold chain

Temperature integrity from origin to destination

Temperature-sensitive products – vaccines, biologics, insulin, certain antibiotics – require unbroken cold-chain control. We plan every cold-chain shipment individually, selecting packaging, route and partners to match the product’s requirements and transit time.

  • Validated passive and active packaging solutions
  • Calibrated data loggers with reports provided to the customer
  • Pre-booked pharma lanes with temperature-controlled handling at transfer points
  • Excursion assessment procedure with manufacturer involvement

Standards and references we work to

Our processes are aligned with internationally recognised guidelines for the distribution of medicinal products and medical devices.

WHO GDP (TRS 957, Annex 5)World Health Organization good distribution practices for pharmaceutical products.
EU GDP Guidelines 2013/C 343/01European Union guidelines on good distribution practice of medicinal products for human use.
WHO Model Quality Assurance SystemQuality assurance system for procurement agencies.
ISO 9001 principlesProcess approach, risk-based thinking and continual improvement.
ISO 13485 (suppliers)Quality management for medical device manufacturers in our supplier base.
Destination-country regulationsImport, labelling and pharmacovigilance rules of each market we serve.

Our commitment against falsified medicines

Falsified and substandard medicines are a serious threat to patients in many of the markets we serve. We take a firm position: we purchase only from manufacturers and authorised distributors with verifiable credentials, we maintain complete chain-of-custody records and we cooperate fully with regulators and manufacturers in any investigation.

  • No purchases from unverified or grey-market sources
  • Verification of serialisation and tamper-evident features where applicable
  • Immediate quarantine and reporting procedure for suspected falsified products
  • Transparency with customers about product origin

Let’s discuss your supply or regulatory project

Tell us which products, markets and volumes you have in mind. Our team replies within one business day with a clear next step.