By Dan Jacob
Life Sciences companies are attempting to improve compliance and manufacturing efficiency while they drive to grow revenue and margins. However, current market conditions are creating substantial headwinds to attaining these targets. Some of these headwinds originate with regulators, both because of increasingly complex global regulation and regulatory oversight, as well as recent FDA expectations that industry shift from a compliance view to an “organizational excellence” view.
Other headwinds come from industry itself. Mergers and acquisitions create operational and organizational fragmentation, fear of regulatory action creates an excessive focus on compliance, and underinvestment in process automation places an undue burden on practitioners. This reduces the time and attention to quality’s role in operational performance, financial performance, and corporate success. Read on to understand strategies, frameworks and recommendations from across LNS’s Quality and Manufacturing Operations practices.