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How TRC Supports Clients ?
Privacy Policy
This privacy policy sets out how The Reg Consultants Pte Ltd uses and protects any information that you give The Reg Consultants Pte Ltd when you use this website.
The Reg Consultants Pte Ltd is committed to ensure that your privacy is protected. Should we ask you to provide certain information by which you can be identified when using this website, you can be assured that it will only be used in accordance with this privacy statement.
To safeguard your personal data, all electronic storage and transmission of personal data is secured with appropriate security technologies.
If you are only browsing this website, we do not capture data that allows us to identify you individually.
What we collect
We may collect the following information:
- Name
- Contact information including email address
- Other information relevant to customer surveys and/or offers
What we do with the information we gather
We require this information to understand your needs and provide you with a better service, and in particular for the following reasons:
- Internal record keeping.
- We may use the information to improve our products and services.
- We may periodically send promotional emails about new products, special offers or other information which we think you may find interesting using the email address which you have provided.
Security
We are committed to ensure that your information is secure. In order to prevent unauthorised access or disclosure, we have put in place suitable physical, electronic and managerial procedures to safeguard and secure the information we collect online.
How we use cookies
A cookie is a small file which asks permission to be placed on your computer’s hard drive. Once you agree, the file is added and the cookie helps analyse web traffic or lets you know when you visit a particular site.
Cookies allow web applications to respond to you as an individual. The web application can tailor its operations to your needs, likes and dislikes by gathering and remembering information about your preferences.
We use traffic log cookies to identify which pages are being used. This helps us analyse data about web page traffic and improve our website in order to tailor it to customer needs. We only use this information for statistical analysis purposes and then the data is removed from the system.
Overall, cookies help us provide you with a better website, by enabling us to monitor which pages you find useful and which you do not. A cookie in no way gives us access to your computer or any information about you, other than the data you choose to share with us.
You can choose to accept or decline cookies. Most web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. This may prevent you from taking full advantage of the website.
Links to other websites
Our website may contain links to other websites of interest. However, once you have used these links to leave our site, you should note that we do not have any control over that other website. Therefore, we cannot be responsible for the protection and privacy of any information which you provide whilst visiting such sites and such sites are not governed by this privacy statement. You should exercise caution and look at the privacy statement applicable to the website in question.
Controlling your personal information
We will not sell, distribute or lease your personal information to third parties unless we have your permission or are required by law to do so.
If you have previously agreed to us using your personal information for direct marketing purposes, you may change your mind at any time by writing to or emailing us at theregconsultants@hotmail.com.
If you believe that any information we are holding on you is incorrect or incomplete, please write to or email us as soon as possible, at the above address. We will promptly correct any information found to be incorrect.
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Terms & Conditions
Welcome to our website. If you continue to browse and use this website, you are agreeing to comply with and be bound by the following terms and conditions of use, which together with our privacy policy govern The Reg Consultants Pte Ltd’s relationship with you in relation to this website. If you disagree with any part of these terms and conditions, please do not use our website.
The term ‘The Reg Consultants Pte Ltd’ or ‘Abbreviated Name’ or ‘Alternative Name’ or ‘us’ or ‘we’ refers to the owner of the website whose registered address is The Reg Consultants Pte Ltd, 1 Irving Place The Commerze@Irving #08-01 S369546. The term ‘you’ refers to the user or viewer of our website.
The use of this website is subject to the following terms of use:
- The content of the pages of this website is for your general information and use only. It is subject to change without notice.
- Neither we nor any third parties provide any warranty or guarantee as to the accuracy, timeliness, performance, completeness or suitability of the information and materials found or offered on this website for any particular purpose. You acknowledge that such information and materials may contain inaccuracies or errors and we expressly exclude liability for any such inaccuracies or errors to the fullest extent permitted by law.
- Your use of any information or materials on this website is entirely at your own risk, for which we shall not be liable. It shall be your own responsibility to ensure that any products, services or information available through this website meet your specific requirements.
- This website contains material which is owned by or licensed to us. This material includes, but is not limited to, the design, layout, look, appearance and graphics. Reproduction is prohibited other than in accordance with the copyright notice, which forms part of these terms and conditions.
- Unauthorised use of this website may give rise to a claim for damages and/or be a criminal offence.
- From time to time, this website may also include links to other websites. These links are provided for your convenience to provide further information. They do not signify that we endorse the website(s). We have no responsibility for the content of the linked website(s).
- Use of this website and these terms are governed by the laws of Singapore. Any claim relating to use of the website shall be heard by Singapore Courts.
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Who We Typically Work With
TRC typically supports companies that:
– Have a defined product and are preparing for market entry in Singapore
– Require alignment of their dossier and regulatory strategy to local requirements
– Need ongoing regulatory support across submission and lifecycle activities
– Prefer a structured and hands-on regulatory approach rather than a transactional service model
Project Fit
TRC may not be the right fit for projects that:
– Are at a very early exploratory stage without a defined product strategy
– Require ad-hoc or one-off support without consideration for lifecycle management
– Are primarily cost-driven without alignment on regulatory scope and requirements
Thank You
Thank You For Your Enquiry
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TRC Services
Regulatory Affairs Support in Singapore
TRC provides regulatory affairs support tailored to companies navigating the Singapore market across pharmaceuticals, medical devices, cosmetics, and health supplements
Understanding Regulatory Requirements
Regulatory requirements in Singapore are not one-size-fits-all. The approach required depends on product classification, data availability, and the intended regulatory pathway.
Misalignment at the early stage often leads to delays during submission or post-approval activities
Our Approach
TRC supports companies through a structured regulatory approach, from initial assessment to submission and lifecycle management, ensuring alignment with local regulatory expectations.
Scope Support
Our support spans across different product categories and lifecycle stages, depending on the specific regulatory needs of each project.
Engage With Us
If you require support for your product or portfolio, you may reach out to discuss your regulatory strategy and next steps.
Who We Typically Work With
TRC typically supports companies that:
– Have a defined product and are preparing for market entry in Singapore
– Require alignment of their dossier and regulatory strategy to local requirements
– Need ongoing regulatory support across submission and lifecycle activities
– Prefer a structured and hands-on regulatory approach
Project Fit
TRC may not be the right fit for projects that:
– Are at a very early exploratory stage without a defined product strategy
– Require ad-hoc or one-off support without consideration for lifecycle management
– Are primarily cost-driven without alignment on regulatory scope and requirements
Pharmaceutical Regulatory Strategy & Lifecycle Management
Pharmaceutical Regulatory Strategy and Lifecycle Management in Singapore
Navigating pharmaceutical regulatory requirements in Singapore requires more than an understanding of submission procedures. Companies are expected to ensure that their regulatory strategy, supporting data, and lifecycle planning are aligned with local expectations prior to submission.
While Singapore is often considered a reference market within ASEAN, regulatory evaluation remains specific to the requirements of the Health Sciences Authority. Differences in dossier expectations, reliance pathways, and product positioning can result in delays if not addressed early.
TRC supports companies in establishing a structured regulatory approach for successful market entry and long-term product maintenance.
Regulatory Strategy Across Different Product Types
The regulatory pathway in Singapore varies depending on product classification, including new chemical entities, generic products, biologics, and advanced therapy products.
While these categories differ in data requirements and evaluation pathways, common challenges are often observed:
- misalignment between reference agency approvals and local expectations
- gaps in dossier structure or supporting documentation
- inappropriate reliance strategies
- incomplete consideration of lifecycle requirements
A structured regulatory strategy is required to ensure that product data is appropriately positioned prior to submission, regardless of product type.
Common Gaps in Pharmaceutical Submissions
In practice, many regulatory delays arise not from lack of data, but from how the data is interpreted and presented.
Typical issues observed include:
- reliance on reference agency approvals without localisation of requirements
- use of WHO or foreign dossiers without adequate gap assessment
- inconsistencies across quality, non-clinical and clinical modules
- deficiencies in justification of specifications or control strategies
Addressing these gaps early reduces the risk of queries, delays, or unsuccessful outcomes during evaluation.
Regulatory Submission and Lifecycle Management
Regulatory obligations do not end at product approval.
Companies are required to maintain their product licences through ongoing regulatory activities, including:
- variations and change management
- licence renewals
- safety and quality updates
- post-market compliance and reporting
Failure to manage these activities appropriately may impact product continuity in the market.
A structured lifecycle approach is therefore necessary to ensure continued compliance beyond initial approval.
Local Representation and Regulatory Responsibility
Pharmaceutical products placed on the Singapore market require a locally registered entity to act as the Marketing Authorisation Holder (MAH).
The MAH is responsible for:
- ensuring product compliance with local regulatory requirements
- maintaining product licences throughout the lifecycle
- managing regulatory submissions and authority interactions
- overseeing post-market obligations
Companies without an established local presence may appoint a suitable partner to fulfil these responsibilities.
TRC’s Approach to Regulatory Management
TRC supports clients on an end-to-end basis, from initial regulatory assessment through to submission, approval, and lifecycle management.
Our approach focuses on:
- identifying regulatory gaps early
- aligning product strategy with local expectations
- managing submissions in a structured and efficient manner
- supporting ongoing compliance and lifecycle activities
Given the complexity of pharmaceutical regulatory work, each project is managed with direct involvement to ensure consistency and accountability throughout the process.
Engaging TRC for Pharmaceutical Regulatory Support
Pharmaceutical regulatory work requires careful planning, technical understanding, and ongoing management.
Whether for new market entry or lifecycle maintenance, a structured regulatory approach is critical to ensure compliance and minimise delays.
If you require support for pharmaceutical regulatory activities in Singapore, you may contact or whatsapp us at TRC to discuss your specific requirements.
Regulatory Representative & Regional Coordination Support
Regulatory Representative & Regional Coordination
TRC supports companies requiring a central regulatory point of contact for ASEAN-related activities, particularly those without an established local or regional regulatory presence.
When You Need This
- You require a local representative in Singapore
- You are entering the Singapore or regional market
- You require coordination between multiple regulatory stakeholders
- You do not have a local regulatory presence
- You require ongoing regulatory support post-registration
Regulatory Representation
- Acting as local representative where required
- Liaison with regulatory authorities
- Support for compliance and regulatory communication
Regional Coordination
- Coordination across ASEAN submissions
- Alignment of regulatory strategy across markets
- Support for multi-market regulatory activities
Approach
TRC supports companies without local regulatory presence by providing structured representation and coordination across Singapore and regional markets.
Contact TRC
Contact TRC to discuss your regulatory requirements.
Why Engage TRC?
FAQs about TRC services
The Shop page lists commonly requested, well-defined regulatory activities with indicative pricing, such as product notifications or specific regulatory submissions. These are typically suitable where scope and regulatory pathways are clear
Yes. TRC regularly supports companies with lean internal structures or without a dedicated regulatory affairs function. In such cases, TRC acts as an external regulatory consultant, providing advisory support tailored to the company’s operational needs and product portfolio.
If you are unsure of the applicable regulatory pathway, scope of work, or if your project involves multiple products or markets, direct consultation is recommended. TRC can assess your requirements and advise on the most appropriate engagement model.
Yes. TRC supports clients with regulatory submissions and product notifications to the Health Sciences Authority (HSA), including pharmaceuticals, medical devices, cosmetics, health supplements and traditional medicines. Support is provided based on the applicable regulatory pathway and product risk classification, and may include submission strategy, dossier review and regulatory liaison
Yes. TRC regularly supports cosmetic and health supplement notifications in Singapore, including assessment of formulation compliance, label review and notification preparation. Support is scoped based on product complexity and regulatory requirements, particularly for products with borderline or higher-risk ingredients.
