Basic Regulatory Support Plan – 40 Hours Monthly

Basic Regulatory Support Plan – 40 Hours Monthly

Flexible, Remote Regulatory Support When You Need It

The Basic Regulatory Support Plan offers 40 hours of expert regulatory assistance per month. It’s designed for companies needing occasional help with regulatory tasks without committing to long-term contracts or full-time staff.

Who Is This Plan For?

• Support for routine regulatory tasks and post-licensing maintenance
• Ad hoc help during busy periods or specific projects
• Short-term regulatory cover (e.g., maternity leave, staff transitions)
• Startups or small teams wanting to reduce overhead and internal training

What’s Included?

• 40 hours of service per month, Monday to Friday
• Assistance with:

• Post-licensing activities like variations and change notifications
• Product classification and document review
• Regulatory strategy advice on specific challenges
• Light project coordination for local markets

Key Benefits

• Pay only for what you use—no long-term contract
• Reduce internal workload by outsourcing to experienced local consultants
• Flexible remote support tailored to your needs
• Upgrade or extend your plan as your business grows

Onboarding Process

1. Purchase the plan through our e-shop. An invoice will be sent for payment.
2. After payment, TRC will contact you to discuss your needs and finalize an NDA.
3. Once onboarded, your 40 regulatory hours start, and work begins.

Terms

• Hours must be used within the subscription month
• All work is done remotely
• One-week notice required for cancellation
• No refunds after cancellation
• Monthly renewals available

Thinking of Registering with HSA? Here’s How We Can Help

When it comes to HSA registration and regulatory support in Singapore, the process doesn’t end once your product is approved. Ongoing compliance, particularly with drug licence variations and medical device change notifications, is a key part of maintaining your regulatory standing. At The Reg Consultants, we offer targeted support to keep your product compliant throughout its lifecycle.

Variation Submissions for Registered Drug Products

Changes such as formulation updates, labelling revisions, addition of new indications, or changes in supplier for a registered therapeutic product often require a variation submission to Health Sciences Authority (HSA).At TRC, we assess the change and determine the appropriate regulatory pathway — whether it qualifies as a Major Variation (MAV-1 or MAV-2) or a Minor Variation (MIV-1 or MIV-2). Our team supports the preparation of the full documentary package and manages the submission process, providing end-to-end regulatory support until the outcome is issued by HSA.We ensure your variation dossier is compliant, complete, and aligned with HSA expectations — minimizing delays and facilitating smooth lifecycle management.

Change Notification for Medical Devices

Post-marketing changes to registered medical devices in Singapore must be assessed and submitted to the Health Sciences Authority (HSA) under the correct change category — administrative, notification, or technical. At TRC, we help you determine: Whether the change requires HSA notification or a new registration, The appropriate category of change and Whether multiple changes can be grouped under a single submission. Our team prepares the complete documentation package in line with HSA’s guidance and manages the submission through to regulatory outcome. We provide end-to-end regulatory support, ensuring that your change notification is accurate, timely, and compliant.

Variation Strategy and Regulatory Impact Assessment

Not all changes to your registered products require the same regulatory pathway. At TRC, we provide early-stage regulatory impact assessments to determine whether your proposed changes trigger a Minor Variation (MIV), Major Variation (MAV), or a new registration under HSA guidelines.

As your regulatory affairs consultant, we help you reduce compliance risks, plan submission timelines, and align internal decisions with Singapore’s regulatory expectations. This proactive approach ensures smoother regulatory outcomes and avoids delays in product rollout.

Lifecycle Compliance Management

Our role as your regulatory affairs consultant doesn’t end with product registration. We provide post-approval regulatory support to help you:

Provide timely, accurate, and well-structured responses to HSA queries, in full alignment with regulatory timelines and expectations.

Submit variations or updates required by business or global changes

Maintain regulatory alignment throughout your product’s lifecycle

Whether you’re managing a new indication, shelf life change, or supplier update, TRC ensures that your product stays compliant as regulations evolve. We offer ongoing HSA registration and regulatory support in Singapore, giving you confidence and continuity across every stage of the product lifecycle.