Welcome to TRC

The most common way where we discuss in our previous article: https://theregconsultants.com/presenting-the-situations-in-which-a-traditional-model-or-an-independent-licence-holding-would-work-best-for-you/  is  to engage a distributor who is well versed in the territory to select products based on their capabilities and complementary to their existing portfolio. Although it saves time and efforts, the two prominent cons that carries with it are not being able […]

Traditional model A traditional model is where by a product owner assigns the marketing and distribution rights on an exclusive basis to a local partner known as distributor that will handle the registration, sales and marketing of their product.  The assignment is through a supply agreement in which it bounds both parties for minimum period […]

Managing a successful therapeutic product licence transfer consists of 3 steps:  Seeking inform consent with Distributor , Selection of an independent license holder and Transfer operation.The licence transfer operation will require some preparation from Product Owner , current marketing authorization holder ( Existing Registrant) and new current marketing authorization holder (new Registrant) .Once the above is completed and a final confirmation from existing registrant that there is no pending renewal nor variations tied to the licences to be transferred, the existing registrant can log on to the online system known as: PRISM to execute the transfer inputting the details provided by Product Owner. Once the initiation of the transfer is performed, the new registrant will receive an email notification to log on to the system to accept the transfer to upload all the relevant documents and details provided by Product Owner. The process takes about 14 working days and both the new registrant and existing registrant will be notified of the outcome. There is currently no cost tied to this operation officially.

Managing regulatory obstacles is a key essential factor in expediting the approval of the products

It’s time of the year again where perhaps this question of setting up a Quality Management System has come up to your mind

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

Healthcare industry remains to be one of the most regulated among all businesses. So how do small companies remain competitive

In my previous blog, we shared briefly on 5 points to look out for when preparing a dossier for submission