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 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 […]
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. […]
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 […]
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 […]
Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that […]
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 […]