Regulatory Affair

Rxedy embodies its Regulatory affairs department in an Outsourcing basis that provides regulatory support, to enhance its processes and consequently make better use of its regulatory strategies.

Rxedy’s core business is focused in Marketing and sales, aiming to be a strategic partner of its manufacturers, in licensing, notification and registration procedures to markets where it operates. Activities regarding our R&D area (research and development), include artworks elaboration, for proper development of registration processes, safety and renewal periodic reports, adaptation document and updating, expert reports, among other activities.

Rxedy owns a qualified regulatory department, with wide experience in dossiers development, evaluation and management, and with the needed skills to a direct cooperation with the processes management department near the local health authorities, with whom intends to keep a close cooperation, in all the domains on the developing projects regulatory field.

 

Pharmacovigilance

Pharmacovigilance it is one activity of shared responsibility between healthcare professionals and patients. Everyone should share all information possible about drugs to achieve optimal use and to identify serious adverse reactions or unknown as quickly as possible in order to prevent or reduce their frequency and severity.

Rxedy has responsibilities on their products such as

- Pharmacovigilance Management;
- Adverse reactions management;
- Adverse reactions database management;
- Adverse reactions recording and reporting to the Health Authorities;
- International scientific literature monitoring;
- Pharmacovigilance plan development and risk management;
- IPS preparation;
- Post-approval studies.