Pharmaceutical and life sciences companies are looking for new ways to improve productivity within their research and development (R&D) organisations to improve their product pipeline. While companies work to tackle the productivity issues through operational and organisational change, the Food and Drug Administration (FDA) and other regulatory entities continue to raise the bar regarding the scope of compliance efforts requisite to manage the risks inherent in R&D processes. Process improvement efforts to more quickly and efficiently bring molecules from bench to bedside necessitate greater financial investments from companies across the discovery, pre-clinical research and clinical development stages. As companies invest in new approaches for conducting and managing both the research and development processes, traditional methods of assessing compliance may not adequately address all of the compliance risks within R&D.
PwC pharmaceutical R&D compliance professionals leverage their deep R&D experience using a proven risk and compliance assessment methodology and include: