Approach
Are regulations a burden or a benefit?
It is the nature of the pharmaceutical business that you invest heavily in R&D (to bring new products and services to treat your patients), in people (whom you train to have the right skills and attitudes), in your infrastructure (to provide a framework and capital assets for manufacture and marketing) and in PROCESSES (to comply with regulations and to build best practices in terms of effectiveness and efficiency).
Whether your strategy is to be the lowest cost producer, or to bring differentiated and unique products to market, the ultimate goal is to focus on highly satisfied end customers – your patients! When you consider the role of the regulator – it is exactly the same! They want patients to be helped and protected by ensuring that certain standards are met.
These are BARRIERS TO MARKET ENTRY that your competitors will have to overcome to be able to challenge your market position. Paradoxically, the raising of the barrier is, therefore, in your best interests. The way that you cement your organisational learnings in GxP compliance could not only be a driver of reduced costs but also allow you to stay ahead of the competition.