Outsourcing Regulatory Lifecycle Management: An Efficient New Model Meets Increasing Global DemandsSource: PPD
In the drive to bring more new products to market sooner, the biopharmaceutical industry is focusing the lion’s share of its regulatory resources on the critical work of managing new product applications and approvals. The urgent need to shorten product development timelines demands greater investment in pre-approval regulatory functions and strategy, but also has the effect of limiting resources for the post-approval regulatory work necessary to maintain product licenses throughout a product’s lifetime—a workload that is increasing, both in terms of volume and regulatory expectations.
Regulatory life cycle management requires ongoing regulatory submissions to maintain a product license in the course of changes in labeling, CMC, other license variations and renewals, and registration of established products in new markets. Traditionally, biopharmaceutical companies have conducted business-critical regulatory functions in-house, but expanding compliance demands, together with shrinking regulatory budgets, are driving the need for outsourcing solutions that can deliver efficient management of high-volume regulatory post approval activities across global markets.
In this paper, PPD discusses an innovative model that adapts the widely used hub-and-spoke outsourcing strategy and structure to the regulatory lifecycle arena. In this model, the service provider centralizes functions that can benefit from lower-cost labor, such as document production and regulatory operations, and maintains local regulatory expertise to provide country-by-country knowledge and experience. This emerging approach enables biopharmaceutical companies to process large volumes of high-quality submissions at lower cost without compromising regulatory relationships.