Should you consider a regulatory subscription plan or adopt a traditional model of hiring your regulatory staff?
A regulatory subscription plan is a newly launched product created by TRC to support medical companies in need of regulatory assistance in a new territory where there is no local office established /when there are only requirement to support post-licensing activities / when additional or alternative support will come in handy when getting the right person on board proves to be difficult/ when you want to explore an alternative way of running your regulatory department /when there are certain conflict of interest between parent company and local company in which an independent party will be useful.
The plan allows you to leverage upon a local expertise to perform the required daily regulatory tasks associated with a typical regulatory specialist and head of regulatory operations. pertaining to the 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
We present a simple comparison chart of Regulatory Subscription Plan Vs Traditional Model.
|Comparison parameters||Regulatory Subscription Plan||Traditional Model|
|Working Principle||Flexible model of rendering regulatory expertise who is already experienced in the local market.||Hiring a staff to manage the regulatory work based on requirements.|
|Cost||It is a fixed cost for experienced personnel.
Can be more cost effective as opposed to having a regular staff if company is just planning on performing post licensing activities and ad-hoc new launched activities .
|Can vary depending on the level of expertise from personnel engaged.
Can incur more cost in the long run and cause distress if company decided to downsize or retrench due to economic outlook.
|Manpower||Resource readily available with years of experience.
Dedicated serving regulatory personnel assigned ( no project manager and etc).
|Need time and resources to train before work can be done.
Dedicated employee .
|Resource allocation and commitment||No commitment basis for the plan.
Able to support various functions which can stretch to pre-product launch such as market research, mediation activities and even audit.
|Commitment required for employment even on contractual basis. If not handled properly might have litigation issues.
“Safe mode” to follow
Fixed duties and function for employee – no flexibility to take on other tasks which is out of scope
|Determining factor in choosing the right model||Have no local office and need someone experienced to kick start the whole process of filing to minimize loss in lead time for product launches.
Limited budget with short time frame on deliverables
Have a non-committed alternative support for the regulatory work to cope with the temporary “lull” period while deciding on the next move for the company or even to support the team while there is internal restructuring which initiatives might still be required to go on.
Have a short trial on a possible operation model of the regulatory function which might be useful in the long run to deal with unexpected circumstances .
|Established presence in the territories for years with good working relationship among partners and staff.
“Expandable budget” to establish own team with a rather flexi timeline
A committed team is essential for the smooth operations of the company.
Fail-safe mode model which worked for many years without resulting in any high turn-over, loss in time and resources to retrain for new employment.
If you have analyzed the chart above and think that it might be suitable to learn more or give it a try, consider to chat up with us using “Contact us” form or even head to the “e-shop” to learn more. We look forward to supporting your initiatives and thanks for your time in reading about this. Do share with your peers who might be in need of this and TRC would be pleased to offer a small token of appreciation for any successful sign-up.