UK pharma companies are scrutinising their budgets more than ever before as a result of inflation, the impact of VPAS / VPAG and Brexit. With Regulatory Affairs departments being cost centres rather than a profit centre, it is only to be expected that we play our part in reviewing where money can be saved.
Generally speaking, it is more challenging to save costs in Regulatory than most other departments in the pharma industry, largely attributed to the nature of the work we do. However, this is not a ‘get out of jail free’ card and instead an invitation to embrace the challenge by getting creative.
I am afraid it starts with planning – in order to know where you can save you need to understand your upcoming submissions and their drivers. If it’s safety related this is obviously non-negotiable, however if it’s CMC related you can ask further questions to determine if it is essential or a nice to have that can be delayed or even cancelled. Your subsequent strategy can further contribute to cost savings.
All possible submission routes for new MAAs should be considered, with the use of the International Recognition Procedure being used where possible – saving both cost and time.
In addition to saving, can you also support your company by enabling sales? Make sure you are in regular contact with commercial and supply chain to prioritise these submissions, which may also include batch specific variations (BSVs) to avoid write-offs.
Our blog goes into a lot more details and also touches on de-branding, headcount and SME status – all great ways to further review opportunities to save money. Be sure to follow us on LinkedIn for more indepth coverage of this over the coming months.
