Work with a committed Regulatory Service Provider to maintain your medical product licenses.
Every regulatory compliance requires the right expertise!
At The Reg Consultants Pte Ltd (TRC), we provide calibrated regulatory affairs management and support since 2017. Our primary focus is to ensure that your pharmaceutical/medical products meet the highest regulatory standards for market access in the ASEAN market.
Why Partner with Us?
We specialise in helping both local and overseas pharmaceutical and medical companies navigate the complex landscape of regulatory affairs and product registration in Singapore. Obtaining the necessary approvals for marketing and distribution is a crucial step in ensuring the success of your products in this diverse and dynamic market. With our expertise, we streamline the registration process, saving you time, resources, and the frustration of bureaucratic hurdles. This not only accelerates your market entry but also ensures compliance with regional regulations, fostering trust and credibility with local authorities and consumers.
Your Path to Regulatory Affairs Compliance: Subscription Plans
Our subscription plans for regulatory affairs are designed to provide you with comprehensive and cost-effective solutions for navigating the complex world of regulatory compliance. Whether you’re a pharmaceutical, medical device, or healthcare company, our subscription packages offer you access to a wealth of regulatory expertise, guidance, and support. Our team of experts will assist you in staying up-to-date with evolving regulations, streamlining product registrations, and ensuring compliance in the ASEAN region.
The ASEAN Joint Assessment Procedure is a procedure in which the same marketing authorization application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs). ASEAN National Medicines Regulatory Authorities (NRAs) includes: Health Sciences Authority (HSA)- Singapore National Pharmaceutical Regulatory Agency (NPRA)- Malaysia Thai Food and Drug Administration (Thai FDA) Food and Drug […]
As a country facing an ageing population and a growing incidence of chronic diseases, it is unsurprising that various pharmaceutical businesses seek to make their products available in Singapore to meet the increasing demand for advanced medical treatments. However, the selling of new pharmaceutical products is heavily regulated in Singapore and is only permitted after […]
Regulatory compliance in the healthcare industry is essential to maintaining quality standards and preventing fraud and abuse, thus ensuring patient safety. However, local and overseas pharmaceutical and medical companies seeking to register their medical products in Singapore may find navigating the numerous regulations governing their operations overwhelming and time-consuming. Due to the dynamic nature of […]
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 […]
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 […]
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 […]
In the world of healthcare, regulatory compliance is the foundation upon which patient safety and industry integrity are built. That is why when it comes to introducing a medical device to the Singaporean market, there are stringent demands of regulatory compliance to ensure utmost safety, reliability and efficacy. In this blog, we delve into the […]
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 […]