Propuesta para la creación de una empresa de asesoría en asuntos regulatorios farmacéuticos orientada a titulares, importadores y fabricantes de medicamentos

Abstract

Marketing of drug products in Colombia, the owners, importers and manufacturers have to comply with the current sanitary legislation related to the regulatory processes applicable to the sanitary registration of the product, as well as to the good practices certifications of the manufacturing and quality control establishments that is granted by the national authority INVIMA; this has generated the need to have the appropriate technical-legal advice to fill such requirements, however, the current offer of consulting firms are mainly focused on the regulatory processes related to the drug product and do not integrate the services aimed at the certifications of the laboratories; this is reason of development of this work that presents a proposal for the creation of a company that is able to satisfy the both needs: comprehensive advice on regulatory issues of drug products and the establishments subject to sanitary compliance. In order to evaluate the viability of this project, a market study was performed that concluded that 73.8% of the respondents have interest in hiring the proposed company. Likewise, the technical and operational study was carried out that allowed defining the most important aspects for the start-up of the business idea; an administrative and legal analysis that allowed to know the organizational structure, strategic orientation and the way to constitute the company under the legal norms; Finally, a financial study was done that showed a viability result of the proposal.