by Patricio Ledesma | Jan 25, 2024 | Regulatory Affairs
Please contact us if you need support to go through the IND application process: info@sofpromed.com The process of bringing a new drug to market is a complex and highly regulated one. Before a drug can be commercialized in the United States, it must be the subject of...
by Patricio Ledesma | Jan 25, 2024 | Regulatory Affairs
If you need support to go through the FDA drug approval process, please contact us at info@sofpromed.com In the world of pharmaceuticals, getting a drug approved by the U.S. Food and Drug Administration (FDA) is a key step before it can be made available to the...
by Patricio Ledesma | May 28, 2018 | Regulatory Affairs
Clinical trials involve several regulatory affairs before, during, and after the research. In Spain, trial sponsors need to interact with the ethics committee (EC) and the competent authority (CA), namely the Agencia Española de Medicamentos y Productos Sanitarios...