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Luis Miguel Meléndez
3 oct 20242 Min. de lectura
Navigating Panama Pharmacovigilance: Guidance on Submitting Periodic Safety Reports, Designation/Update of Pharmacovigilance contacts and other submisions on the FADDI platform
In the realm of pharmaceutical regulatory affairs, staying abreast of updates and guidelines is crucial for companies seeking market...
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Luis Miguel Meléndez
3 oct 20242 Min. de lectura
Navigating Peruvian Orphan Drug Approvals Under Law 31738: What To Expect and How to Move Forward
In a recent development for the pharmaceutical industry in Peru, the regulatory authority, DIGEMID, has issued Notice "COMUNICADO N°...
46 visualizaciones
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Camila Moreno
21 abr 20231 Min. de lectura
New Transitory Process in Panama for Submission of Variations through an Electronic Platform
A transitory process is established to receive procedures for the modification of sanitary registrations obtained through an electronic...
15 visualizaciones
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Camila Moreno
12 abr 20231 Min. de lectura
Venezuela requiring submission of GMP certificate(s) of Drug Substances for sanitary registrations
As of July 1, 2023, it will be mandatory, for applications for Sanitary Registration and post-registration changes that require it, to...
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Luis Miguel Meléndez
20 ene 20231 Min. de lectura
Additional HIV IVD devices Will Need Pre-Marketing Approvals in Chile by December 22 and December 23
Recent regulatory updates in Chile, made it mandatory to obtain pre-marketing approval in order to sale several types of IVD-MDs for HIV...
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17 mar 20221 Min. de lectura
RAPS Convergence 2022: See you at Phoenix Arizona
Luis Meléndez, Sr. Regulatory Affairs Manager RAFINT, will be attending the RAPS Regulatory Convergence at the Phoenix Convention Center...
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