Marken announced that they have secured two new operating licenses in Argentina which will provide clients with a full supply chain service in that country.
The two licenses will allow Marken to receive, store and distribute medication, lab kits and ancillary supplies throughout the entire country. The 'Operator Logistico' license was approved by Ministry of Health (MOH) of the Province of Buenos Aires. The second license: 'Distribuidora y Operador Logistico de Medicamentos' was issued by ANMAT (National Administration of Drugs, Foods and Medical Devices).
Growing the number of clinical trials in the country has become a particular focus for ANMAT and they are working closely with the Provinces to promote clinical research. However, the application and license processes are still quite complicated and lengthy and, once granted, are heavily enforced. The MOH and ANMAT will perform unannounced GMP inspections and ensure compliance with all regulations to ensure the continued safety of the clinical supply chain and ultimately, assure patient protection. Marken's own internal GMP standards, which are based on pharmaceutical industry best practices, are robust. They have passed their client's expectations and regulatory requirements around the world.
Wes Wheeler, Chief Executive Officer for Marken, commented, "Marken is proud to be a part of the Argentina pharmaceutical industry. We are now a fully independent logistics provider in the country with our own legal entity and all required licenses which enable us to provide services to all of our clinical research clients. We are privileged to be part of the growing research community in Argentina."
Marken is also in the process of applying for a Secondary Packaging License which will offer clients the opportunity to utilize Marken's secondary packaging services in that country.