What is a ASEAN CTD ?

In my previous blog, we shared briefly on 5 points to look out for when preparing a dossier for submission. In the process of compilation of documents, you often hear your Southeast Asia partners mention about a specific format for submission which is the ASEAN CTD. So what is ASEAN CTD? ASEAN CTD stands forContinue reading “What is a ASEAN CTD ?”

5 quick questions to check before regulatory filing of pharmaceutical products in ASEAN

To many of the principals out there, ASEAN remains one of the biggest untapped market . But yet, there are many “mysteries” surrounding the ASEAN’s regulations. for filing of pharmaceutical products. Common questions encountered are like: What are the regulatory requirements? What are the obligations as a marketing authorization holder? What business model would beContinue reading “5 quick questions to check before regulatory filing of pharmaceutical products in ASEAN”