News & Articles

The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today […]

Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like to […]

  As a regulatory service provider aka consultant, each regulatory consultant has their own unique way of execution of regulatory task especially for regulatory submission.  However it would not differ too much from what we are going to share with you. TRC would like to share with potential prospects of how we usually manage regulatory […]

Many companies expanding into a new territory such as Singapore or ASEAN initially consider setting up a local regulatory function or hiring a full-time regulatory staff. However, in practice, this approach may not always be efficient — particularly during early market entry, when product pipelines are still being established or when regulatory workload is not […]

Registration of a medical product starts with an official classification  which will determine the documentary requirements, timelines, and fees. Today we are going to share a few misconceptions and the approach to classify a product correctly. Misconception We assume that the classification in the country of origin will be the classification in the country to […]

As pharmaceutical companies worldwide continue to expand their global reach, navigating the intricate landscape of international markets becomes an increasingly complex endeavour. In this era of heightened regulatory scrutiny, pharma companies must be well-versed in the multifaceted world of regulatory affairs in order to successfully expand their operations beyond borders. We’ll explore the indispensable role […]