Overall Description

Regulatory Subscription Plan

The Regulatory Subscription Plan is a tailored yet flexible model for delivering operational regulatory services to medical companies at all stages of the business development lifecycle. It functions similarly to a non-commitment mobile plan or G Suite, allowing you to pay only for the services you need. Each plan includes specific hours allocated to permissible activities and can be customized based on your business requirements.

This plan primarily covers:

• Routine operational tasks on an ad-hoc basis
• Support during peak periods
• Short-term maternity cover related to specific regulatory initiatives
• Project management from an ASEAN perspective

With this plan, you can save time and money by reducing the need to hire operational staff and minimizing internal training resources. It allows you to leverage experienced local regulatory expertise to execute tasks within the set timeframe, all while capping hours to eliminate concerns about rising costs associated with outsourced support.

Onboarding Process

The onboarding process is straightforward:

1. Purchase: You make a purchase via our E-shop, after which an invoice will be sent to initiate a bank transfer for payment. There are no recurring charges that lock your credit card.
2. Payment Confirmation: Once payment is received, TRC will contact you to schedule a meeting to discuss the activities to be completed within the agreed timeframe and sign a Non-Disclosure Agreement (NDA) before executing any activities.
3. Task Execution: After the meeting, you will send the necessary materials to TRC, who will complete the task. Once finished, TRC will send back the deliverables for your review.

Plan Tiers

There are two tiers to the plan:

1. Basic Regulatory Subscription Plan: 40 hours
2. Advanced Regulatory Subscription Plan: 80 hours

You can purchase the plan for durations ranging from as short as one month to up to 12 months, depending on your needs. Importantly, this plan is commitment-free.

Details about the plan:

The Regulatory Subscription Plan (Basic) is a pre-paid plan that is suitable for overseas companies who are looking for some initial regulatory support for exploratory activities pertaining to their pharmaceutical products, companies who has lean regulatory framework within but require some form of regulatory support such as ad-hoc consultation on business activities on a as and when required basis and  companies that wishes to get some external help to support some maintenance of the existing product licenses so that internal team could focus on more important objectives.

Plan Inclusions

The Regulatory Subscription Plan (Basic) includes the following:

• 40 hours of service in the month of sign-up, available Monday to Friday.

The plan covers the following activities:

• 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.

Terms and Conditions

• Fees: Fees are collected on a monthly basis.
• Usage: All hours must be utilized within the month of subscription.
• Remote Work: The plan is applicable for work conducted on a remote basis.
• Termination: A one-week notice is required for termination, mutually agreed upon. A handover will occur on the agreed date. No refunds will be issued upon termination.
• Renewal: The plan is renewable on a monthly basis or as needed. A renewal reminder will be sent one week prior to the expiration of the plan.
• Commencement: Work will only begin upon successful verification of payment.