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”

List of essential documents for ISO 13485:2016

With the implementation of ISO 13485:2016, many companies are rushing to comply to the latest addition. The Reg Consultants Pte Ltd has prepared a list of essential documents for medical device companies to download in implementing and preparation of a transition audit for ISO 13485:2016. So subscribe now to get the free checklist over here!

Do regulatory personnel need to be commercial savvy?

When I used to work in big corporations in the regulatory department, the mindset was to do what we need to do in our department and we don’t really need to know so much about the other operations of the company. Apart from dealing with close deadlines, we would have to manage our “commercial colleagues”Continue reading “Do regulatory personnel need to be commercial savvy?”