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How TRC Supports Clients ?
Privacy Policy
Last Updated: [July 2026]
At The Reg Consultants Pte Ltd (TRC), accessible via
This Privacy Policy explains how we collect, use, disclose, and manage the personal data you provide to us when seeking our regulatory affairs management and consulting services.
1. Personal Data We Collect
We only collect personal data that is voluntarily provided and reasonably necessary to process your business inquiries. This may include:
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Name
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Job Title / Company Name
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Business contact details (such as email address and phone number)
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Any specific product, project, or regulatory details you share when submitting an inquiry or requesting a quotation.
2. Purposes for Collection, Use, and Disclosure
We collect and use your personal data strictly for the following professional business purposes:
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Responding to your regulatory inquiries, feedback, or requests for compliance information.
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Preparing, calculating, and providing business quotations or subscription plan details for our regulatory services.
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Communicating with you regarding a quotation or service contract you have initiated.
Our Anti-Spam & Marketing Policy: TRC does not send promotional or marketing emails. We will never use your personal data for telemarketing, newsletters, or direct marketing purposes without your explicit, separate consent, nor do we sell or rent your data to third parties.
3. Disclosure of Personal Data
As a regulatory service provider, we understand the critical importance of confidentiality. We do not disclose your personal data to external parties unless it is strictly necessary to fulfill your request (such as secure IT infrastructure vendors hosting our website), or where required by law or local health authorities (e.g., Health Sciences Authority – HSA) in the direct course of authorized project management.
4. Protection and Security
We implement robust technical, administrative, and physical security measures to safeguard your personal data from unauthorized access, collection, use, disclosure, copying, modification, or disposal.
5. Retention of Personal Data
We will only retain your personal data for as long as it is necessary to fulfill the purposes for which it was collected (such as evaluating a potential project or managing a quotation relationship) or as required to comply with legal, regulatory, or business accounting requirements in Singapore. When no longer required, data is securely deleted or anonymized.
6. Access and Correction Rights
Under the PDPA, you have the right to request access to a copy of the personal data we hold about you, or to request corrections to any errors or omissions in your data. To submit a request, please contact our Data Protection Officer (DPO).
7. Contacting Our Data Protection Officer (DPO)
If you have any questions, feedback, or requests regarding this Privacy Policy, please contact our designated DPO at:
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Attention: Data Protection Officer
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Email: enquiries@theregconsultants.com
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Address: Centennial Tower, 21st Floor, 3 Temasek Avenue, Singapore 039190
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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
We have received your comments and have sent a confirmation email to your inbox. We thank you for your enquiry and will respond to you shortly.
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.
