AI-powered regulatory affairs

RA professionals and senior management face a myriad of obstacles in their day-to-day business, ranging from rapidly evolving global standards that create compliance gaps to manual processes that increase costs and error risks. The complexity of the diverse regional requirements, together with lengthy approval processes, further complicates market expansion and supply chain efficiency – leading to delays in time-to-market and thus revenue generation.

The high price of inefficiency in regulatory affairs

The financial and reputational consequences of inefficient RA practices can be severe. Penalties for non-compliance, delayed approvals and redundant workflows negatively impact profitability. Errors in submissions or product recalls can damage stakeholder trust and a company’s reputation. Moreover, the disproportionate allocation of RA teams’ time to manual tasks leaves little room for strategic priorities, hindering overall business growth.

AI-powered solutions present a transformative answer to the challenges facing regulatory affairs. Automated document generation, submission tracking and error flagging can reduce manual effort by over 50%. Predictive compliance capabilities using machine learning enable companies to be proactive in carrying out risk assessments and adapting to regulatory changes. AI-driven, global harmonisation streamlines the market-entry process by mapping the diverse regional requirements. Real-time analytics empower enhanced decision-making, optimising resource allocation and submission strategies.

Utilising AI is not without risk

While the potential of AI is clear, it’s crucial to approach its implementation with care and foresight. AI systems are not infallible – they can be susceptible to ‘hallucinations’, whereby plausible-sounding yet inaccurate outputs are produced. This underscores the need for a human lead with oversight and validation of outputs. Additionally, the sensitive nature of regulatory data calls for attention to data security and cybersecurity measures to protect against breaches. Ensuring high-quality, reliable data is also paramount, as the integrity of AI-generated insights and subsequent decision-making hinges on the quality of the underlying information. 

The foundation for lasting impact

Developing a solid business case for AI adoption in regulatory affairs is the key to sustained value for an organisation. The specific needs depend on the company’s set-up and current AI adoption status. A first step could incorporate a cost-benefit analysis. Key ROI drivers might include reduced labour costs, faster approvals and mitigated penalties. For example, a mid-sized pharma company may be able to cut its submission preparation time by 60% and accelerate its time-to-market by 25% through the implementation of AI tools. The implementation roadmap typically involves auditing current workflows, piloting AI solutions and scaling the technology, together with integration support and employee training.

PwC, as a global leader in AI-driven solutions, is investing CHF 50 million to expand and scale its capabilities in Switzerland. Our cross-functional subject matter experts in the pharma and life science industry and artificial intelligence guide our clients through the entire journey, from identifying AI-ready processes to ensuring ongoing compliance alignment and tracking tangible ROI metrics. We also provide change management support to upskill RA teams and foster AI adoption within our clients’ organisations.

Getting started

The time to harness the power of AI in regulatory affairs is now. A collaborative, diagnostic audit can help your organisation to identify AI-ready processes and assess the potential for efficiency enhancement. 

PwC is ready to act as your trusted partner in this transformative journey, empowering your RA function to drive compliance, efficiency and strategic growth. Our experts look forward to talking with you in person.