Regulatory lifecycle maintenance outsourcing
A regulatory agency expectation for the sponsor following the registration of a therapeutic good in Australia or New Zealand is keeping the licence up to date. This is undertaken through submitting variations to the TGA or Medsafe to implement changes to the product and providing the TGA or Medsafe with information upon request. The activities of maintaining the registration are known as regulatory lifecycle maintenance. Regulatory lifecycle maintenance covers safety changes, manufacturing changes and commercial changes, which can be varied and challenging.
Regulatory lifecycle maintenance challenges
While the principles of regulatory lifecycle maintenance seem straight forward in submitting information to the TGA or Medsafe to implement changes and in response requests there are an array of variables and challenges that need to be considered to complete them. Understanding the appropriate regulatory pathway, ensuring the required data is available and supports what is proposed, meeting the required deadline to ensure the change can be implemented without impacting supply and even the format and file naming of the data to be supplied to the agency are all examples of the complexities that need to be considered.
Some of these complexities need experience such as understanding the requirements, others require an initial significant financial outlay such as specialist software for eCTD dossier publishing, but all require time to understand how they fit together to allow the correct process to be followed.
Regulatory lifecycle maintenance activities
Commercial Eyes can support sponsors with their regulatory lifecycle maintenance activities to ensure they meet their legal sponsor obligations. Commercial Eyes utilises a state-of-the-art project management tool, document management system and specialist publishing software (Lorenz docuBridge, which is utilised by the key global regulators including the TGA) to provide sponsors with the level of support required by each sponsor. Here are some different options of support models that may benefit sponsors:
Full regulatory support
The most appropriate option for sponsors with limited regulatory presence in Australia and New Zealand. In this scenario, Commercial Eyes takes on the role of the regulatory department for the sponsor. It is a cost-effective option allowing sponsors access to a team of experienced regulatory professionals while paying only for the regulatory activity required throughout the year, rather than ongoing employment costs.
Commercial Eyes liaises directly with the product manufacturers or global contacts and with the regulatory agencies in Australia and New Zealand, ensuring ongoing compliance with commitments and the project management of all regulatory activities.
Select product range support
An ideal option for sponsors with an established regulatory presence in Australia and New Zealand, but with capacity or head count constraints. Sponsors allocate their internal resources to the product range with greater commercial significance or greater professional development opportunity for their team members and outsource the regulatory activities for an established product portfolio. Commercial Eyes can work through the sponsor or liaise directly with the product manufacturers or global contacts and with the regulatory agencies in Australia and New Zealand, ensuring ongoing compliance with commitments and the project management of all regulatory activities for the select product range.
Select regulatory activity support
An ideal option for sponsors requiring support with a project such as an acquisition or for activities sponsors do not have the desire, expertise or technology/equipment to undertake internally such as publishing. In this scenario, Commercial Eyes undertakes the specific activity required by the sponsor, while the sponsor undertakes the remainder of the regulatory lifecycle maintenance. Commercial Eyes can work through the sponsor or liaise directly with the product manufacturers or global contacts and with the regulatory agencies in Australia and New Zealand. For activities such as publishing that require specialist software, outsourcing removes the significant cost and time investment for the sponsor.