Compliance is the operating system.
Every product we trade is sourced, stored, transported and documented against international standards.
GDP & WHO-GMP
Distribution and sourcing aligned with Good Distribution Practice and WHO-GMP standards.
Temperature control
Validated cold-chain with continuous monitoring and qualified packaging solutions.
Traceability
Batch-level serialization and end-to-end track & trace, with anti-counterfeit measures.
Pharmacovigilance
Adverse event capture, reporting and quality complaint management.
Regulatory authorities we work with
We are registered with and report to the regulatory authorities that govern the markets we serve, including the SFDA (Saudi Arabia), MOH (UAE), EMA (European Union), MHRA (United Kingdom), TGA (Australia), ANVISA (Brazil) and equivalent ministries of health across the GCC, MENA and Africa.
Downloadable certificates
Our current quality certificates and trading licenses are available below. Contact us for the latest signed copies issued for your market.
Frequently asked questions
We operate under ISO 9001, ISO 13485 and GDP, and source exclusively from WHO-GMP / EU-GMP qualified manufacturers. We hold the national licenses required for the markets we serve, including registrations with SFDA, MOH, FDA, EMA and MHRA.
Qualified shippers, real-time temperature loggers, validated handling SOPs and 24/7 deviation response procedures.
Yes — our Regulatory Affairs team prepares CTD/eCTD dossiers, manages variations and acts as local representative where required.
All complaints are logged in our QMS, investigated against retained samples and reported per local pharmacovigilance obligations.