E-mail: info@redsinergica.com ; asesorias.regulatorias@gmail.com
Mobile Phone: (57)3192343419, Bogota, Colombia , South America
 |
CLINICAL TRIALS AND PHARMACOVIGILANCE |
|---|
Clinical trials are essential in the research and development phases of a drug because through these the effectiveness and safety of the same is determined.
The execution of such trials in Colombia is regulated by INVIMA, entity responsible for granting permission to carry out these studies, therefore, the preparation of clinical documentation for submission to the INVIMA, should be very careful and detailed.
License Holders of drug products must submit constantly drug pharmacovigilance reports to INVIMA. Likewise Health Institutions in Colombia such hospitals must perform this task regularly.
Red Sinérgica Regulatorios has a multidisciplinary professional team in order to provide expert advice in the preparation of clinical documentation and pharmacovigilance reports and associated steps and procedures, with the final goal to stay in regulatory compliance with INVIMA:
