Medicines - Colombia

The firm has experts led by Pharmacologists, Toxicologists, Epidemiologists, Pharmaceutical Chemists, who provide advice and support in relation to the sanitary regime, sanitary surveillance, Sanitary Registry, certifications and audits of GMP and GLP.

Aruna Asesores, through the scientific and technical division, provides advice and support, helping pharmaceutical laboratories have a multidisciplinary team expert in Colombian health regulations.

In Colombia, it is necessary that the molecules, their concentrations and associations, have been previously approved by the drug review commission or new molecules, to be registered and obtain the required marketing permits; The scientific and technical team of Aruna Asesores tends to ensure that companies from the beginning have adequate information and the processes that manage regulatory affairs in Colombia.

Aruna includes pharmacovigilance processes within the services for the category of medicines. In the scientific direction, through expert doctors, systems are designed according to the processes carried out by each company and makes the development, execution and monitoring of all the pharmacovigilance processes that the country requires available to companies.

Colombian regulations establish the possibility of obtaining special permits for some medicines, if they are considered Vital and not Available, in these cases the team of professionals provide support to companies to obtain regulatory guarantees.