Dos and Don’ts in a regulatory consultation meeting
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 […]
Steps to incorporate new regulation changes in approved marketing authorization (MAs)
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 […]
TRC’s way of managing regulatory submission flow
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 submission. […]
Should you consider a regulatory subscription plan or adopt a traditional model of hiring your regulatory staff?
A regulatory subscription plan is a newly launched product created by TRC to support medical companies in need of regulatory assistance in a new territory where there is no local office established /when there are only requirement to support post-licensing activities / when additional or alternative support will come in handy when getting the right […]
What is a borderline medical device in ASEAN terms and published list for your reference?
This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise. A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases and possibly contain agent or […]
An introduction to registration requirements of Chinese Proprietary Medicines(CPM) in Singapore
Chinese Proprietary Medicines(中成药产品) refers to finished medicinal product, such as a capsule or tablet, and contains one or more active ingredients from any plant, animal or mineral, or any combination of sources. All the active ingredients must be documented for use in traditional Chinese medicine. Prior to importation and distribution of CPM in Singapore, CPM […]