Regulatory Affairs

Advance Regulatory Subscription Plan

SGD 5,000.00SGD 60,000.00


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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:

The Regulatory Subscription Plan (Advance) is a pre-paid plan that is  suitable for companies who has established a presence in ASEAN market but with no regional RA to oversee activities but with a regional business manager , companies who has established portfolio but wants to explore an alternative source to support to tie out peak periods, companies who has a mature portfolio but requires someone to perform fix routine activities above, companies who are establishing their local office and  wants someone to run these regulatory activities while awaiting transfer or hiring own staff. Companies who are building their product portfolio that requires a constant support of a acting local staff.

The plan includes the following:

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

The following activities that can be covered:

  • Review of product dossier to align with local regulatory requirements not covering registration and submission activities
  • Management of local distributor’s RA
  • Project management support as a regional RA
  • Post licensing activities: variations, change notification, annual product review activities by HQ.
  • Support for regulatory audit
  • Strategy regulatory assessment to align with regulatory initiatives or business initiatives  

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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