How to review and plan for the next regulatory cycle of activities

It has come to the end of the year where budgeting and planning are in full force for 2024. In regulatory, we do it via the RPA way which stands for Review, Plan and Act . TRC shall share a short summary on what RPA means : Review Start off with product annual review to […]

11 Dec 2023 |
Pharmaceutical Consulting

5 tips of regulatory project management in ASEAN

During the expansion of territory in the traditional business model, there will be multiple distributors that manufacturers must deal with. Unlike big companies that have a dedicated staff looking after the region. Smaller companies or companies that do not have a local office established in the territory will rely on their business manager who might […]

29 Nov 2023 |
Pharmaceutical Consulting

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 […]

20 Nov 2023 |
Pharmaceutical Consulting

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 to […]

14 Nov 2023 |
Pharmaceutical Consulting

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 […]

06 Nov 2023 |
Pharma Registration

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 […]

23 Oct 2023 |
Regulatory Consulting Services

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!