Advanced Regulatory Support Plan-80 hours

Structured regulatory capacity for ongoing regulatory operations across Singapore and ASEAN

Overview

The Regulatory Support Plan (Advanced) is  designed for companies that have established a presence in the ASEAN market but lack a regional regulatory affairs (RA) representative to oversee activities.

This model is typically engaged where regulatory activities are ongoing, involve multiple stakeholders, or require sustained operational oversight.

The Basic Regulatory Support Plan offers 80 hours of expert regulatory assistance per month.

When this model is used

• Companies with a regional business manager who need additional support during peak periods
• Companies that have a mature product portfolio but want to explore alternative sources of support for routine activities.
• Companies establishing a local office that require someone to manage regulatory activities while awaiting the transfer or hiring of their own staff.
• Companies building their product portfolio that need consistent support from an acting local staff member.

What this model supports

• Project management support as a regional regulatory affairs (RA) representative
• Post licensing activities: variations, change notification, annual product review activities by HQ.
• Strategy regulatory assessment to align with regulatory initiatives or business initiatives
• Regulatory strategy and impact assessment support

How engagement works

Engagement is structured as a monthly regulatory support model.

The scope is aligned based on regulatory workload, product portfolio, and operational requirements.

This ensures consistent regulatory continuity while maintaining flexibility as business needs evolve.

When this model may not be suitable

• Occasional or ad-hoc regulatory assistance only
• Fully established in-house regulatory team with sufficient capacity
• No ongoing regulatory activity or submissions

Key benefits

• Continuous regulatory support without hiring full-time staff
• Increased capacity for multiple concurrent regulatory activities
• Reduced reliance on distributor-led regulatory handling
• Improved lifecycle continuity and compliance management
• Greater responsiveness to regulatory changes

Onboarding process

Engagement begins with a discussion to understand regulatory requirements and scope of work.

Support scope is aligned prior to commencement.

An invoice is issued upon confirmation, and onboarding begins thereafter.

Commercial terms

• Monthly engagement basis (80 hours per month)
• Remote delivery only ( Monday to Friday)
• Minimum one-month engagement
• One-week notice for termination
• Non-refundable once work commences
• Monthly renewal basis