Basic Regulatory Support Plan- 40 Hours Monthly

Structured regulatory support for defined regulatory activities and ongoing maintenance in Singapore

Overview

The Regulatory Subscription Plan (Basic) is a prepaid plan tailored for overseas companies seeking initial regulatory support for exploratory activities related to their pharmaceutical products. This plan suits companies with a lean internal regulatory framework that require occasional support, such as ad-hoc consultations on business activities. It also benefits companies seeking external assistance with maintaining existing product licenses, allowing their internal teams to focus on core objectives.

The Basic Regulatory Support Plan offers 40 hours of expert regulatory assistance per month.

When this model is used

• Early market entry into Singapore
• Occasional regulatory workload or ad-hoc support needs
• Small teams without dedicated regulatory personnel
• Interim support during internal transitions or peak periods

What this model supports

• Regulatory Intelligence: Assessing category, pathway, and documentary requirements for products.
• Business Advisory: Providing regulatory input to address feasibility and risks associated with business questions.
• Consultation: Assisting with ad-hoc regulatory issues related to business plans and market launches.
• Local Representation: Consulting with regulatory authorities on formal issues surrounding product registration and operational initiatives.
• SOP Updates: Updating operational Standard Operating Procedures (SOPs).
• Regulatory Database Maintenance: Keeping regulatory databases up to date.
• Training: Conducting training for distributors based on materials prepared by the client.
• Daily RA Work: Responding to emails from principals, assessing business plans for regulatory compliance, and attending ad-hoc meetings as the company’s RA representative.

How engagement works

Engagement is structured as a monthly regulatory support model.

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

This ensures companies receive targeted regulatory support without committing to a full in-house function.

When this model may not be suitable

• Companies requiring continuous multi-product regulatory management
• High-volume ongoing submissions or lifecycle activities
• Fully established in-house regulatory teams with sufficient capacity

Key benefits

• Access to experienced regulatory expertise without full-time hiring
• Flexible support for defined regulatory activities
• Reduced internal training and onboarding burden
• Efficient handling of post-licensing and maintenance tasks
• Ability to scale support based on workload

Onboarding process

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

The appropriate level of support is aligned prior to commencement.

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

Commercial terms

• Monthly engagement basis (40 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