Regulatory Affairs

Basic Regulatory Subscription Plan

SGD 3,000.00SGD 36,000.00

Regulatory subscription plan is a product that is designed to support companies who has lean regulatory framework from the start and do not require extensive on site support of  a regular employee. The purpose could be to perform some basic operational works on an adhoc basis, tie over peak periods, maternity cover for a short period of time relating to specific regulatory initiatives or even project management from a ASEAN perspective.


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Overall Description

Regulatory subscription plan is a tailored yet flexible model of rendering operational regulatory services to medical companies in all phases of the business development lifecycle. It functions just a like a non-commitment mobile plan or G-suite where you pay for what you need to cover the required activities. Each plan has a specific hours tied to it with a list of permissible activities and could be purchased based on your business needs.

Primarily, The plan could cover routine operational works on an adhoc basis, tie over peak periods, maternity cover for a short period of time relating to specific regulatory initiatives and  project management from a ASEAN perspective.

The plan allows you to save time and money in looking for a operational staff, reduce internal  resources and time to train before the work can be performed,  allows you to leverage and utilize experienced local regulatory expertise  to perform the work for you based on your objectives within the set timeframe within plan you purchased, eliminate the worry of rising cost in utilizing outsourced support with capped hours.

Onboarding process is simple: First you make a purchase via E-shop, an invoice will be sent to you for you to initiate bank transfer to pay for the plan, it does not lock your credit card for any recurring payment. Once payment is received, TRC will  contact you to schedule a date for discussion of activities to be completed within the timeframe and to sign an NDA with your company before any execution of activities . Once the meeting is done, Client will send materials over for TRC to complete the task. Once task is completed, TRC will send back the deliverables for the Client to review.

There are two tiers to the plan one  which is termed as the basic regulatory subscription plan (40 hours) and the advance regulatory subscription plan (80 hours).  The period of the plan that you can purchase could range from as short as 1 month to 12 months depending on your needs.  It 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 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, 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.

The plan includes the following:

  • 40 hours of services in the month of sign-up on Monday-Friday

The following activities that can be covered:

  • Regulatory intelligence work to assess category, pathway and documentary requirements of products
  • Business question that requires regulatory input to advice on feasibility and risks involved.
  • Consultation on ad-hoc regulatory issues revolving around business plans and market launches
  • Local representation to consult regulatory authority on formal issues surrounding product registration or operational initiatives
  • Updating of operational SOPs
  • Maintenance of regulatory databases
  • Conduct of training to distributors based on materials prepared by Client

Terms and Conditions:

  • Fees are collected on a monthly basis.
  • All hours will have to be exhausted within the month of subscription.
  • Applicable for work conducted on remote basis.
  • Termination: 1 week notice mutually agreed. Upon termination, a handover will be done on the agreed date. No refund can be sought upon termination.
  • Renewable on a monthly basis or as and when required. Renewal reminder will be sent one week prior to expiry of plan.
  • Work will only commence upon successful verification of payment.
If you have any specific regulatory questions pertaining to entering the Singapore market — feel free to reach out.

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