Our client submitted a Marketing Authorisation Application for a new pharmaceutical product to be supplied for the first time outside their local market. The product was to be launched in over 20 countries including the EU, Canada, CIS and MENA, with the MHRA acting as a reference member state (RMS) in a Decentralised Procedure (DP).
The client had no infrastructure outside their local market, contracting a network of third party manufactures to develop and make the new product and had limited supply chain management capability globally.
Regulatory challenges resulted in product launch delays impacting revenue and market share and increasing costs. Launch dates were being moved back and pressure was being exerted by the parent company to launch as early as possible. In order to prevent costs spiralling out of control and to bring launch deadlines back on track programme and risk management was required urgently.
The client required support in creating a future operating model strategy and business case to convince their parent company that this business is viable and recognised that they would then need support to translate the operating model strategy into reality and start generating revenues as soon as possible.Our approach
PwC utilised a small and targeted team with specific skills aligned to the objectives of the programme.
The PwC team contributed:
These operating model options focused on collaboration between the client and the network of third party providers to ensure the best possible opportunity for them to meet the tight launch deadlines.The outcome
The PwC team enabled the client team to focus their activities by producing a programme plan and highlighting associated risks, leading to a positive choice of operating model strategy within 3 weeks. This translated into a broader vendor selection process and the joint creation of a target operating model with a preferred service provider.
Benefits to client management team: