We specialize in Good Manufacturing Practice (GMP)
We specialize in Good Manufacturing Practice (GMP) compliance for the safe export of South African cannabis to Europe. Our services include up-to-date guidance, practical implementation support, and safety for daily routine activities. We ensure that all stages of manufacturing of medicinal products destined for EU sale adhere to EU GMP guidelines, guaranteeing consistent manufacturing processes with quality standards met throughout.
Our team provides expertise in Qualified Person (QP) certification and quality control testing of imported medicinal products. We also offer Importer of Record (IoR) services, ensuring compliance with local laws and regulations. Our Responsible Person (RP) services ensure your supply chain complies with current Good Distribution Practice (cGDP).
We adhere to the minimum standard of GMP for every medicines manufacturer during production processes. The European Medicines Agency (EMA) coordinates inspections to check compliance with GMP standards, and plays an essential role in unifying GMP activities across Europe.
We comply with EU GMP guidelines and possess authorizations from the national competent authority in each member state where we conduct manufacturing or import activities. We ensure that any proposed manufacturing sites included in our marketing authorization applications comply with GMP requirements.
We are committed to international collaboration and have mutual recognition agreements on GMP inspections between regulatory bodies outside the EU and EU authorities.
