Author: Darryl Clark, Sciformix Corporation
More than ever before, life sciences organisations are being challenged to bring new and improved products to market faster, with fewer resources and in an environment where failure to comply with regulatory requirements can result in costly penalties. In addition, companies are expanding into new geographical areas as they pursue business expansion, mergers and acquisitions, and extension of product longevity. This need to cater to disparate requirements across regions can, in many cases, slow down processes and reduce operational efficiency and profitability, while delaying time-to market of these products.
Furthermore, regulatory mandates are becoming more stringent and the need for automation, technology, process excellence and global knowledge is paramount. Great strides have been made within the industry to harmonise these requirements and the adoption of standards like Common Technical Document (CTD), electronic Common Technical Document (eCTD) and none CTD electronic Submissions have simplified and streamlined interactions with health authorities. In addition, to comply with the evolving regulatory mandates, cope with higher volumes and manage the resources that are spread across multiple geographies, firms are turning to outsourcing, and are partnering with vendors that specialise in regulatory affairs and operations.