Regulatory and compliance consultancy, Maetrics, has released a whitepaper highlighting how the COVID-19 pandemic is affecting regulatory and quality compliance in the life science sector.
This whitepaper aims to offer insights on how to meet current global healthcare needs and analyse specific quality and regulatory issues that have arisen since the start of the pandemic. Additionally, it includes a discussion of the strategic approach needed to provide effective regulatory and quality support across the entire organisation, as well as a comprehensive checklist for regulatory affairs and quality assurance professionals to be used to assess internal readiness for existing and upcoming regulatory changes.
Steve Cottrell, president at Maetrics, said: “Though this has undoubtedly been a challenging time for the industry, the need to re-assess operations may also reveal opportunities for increased business efficiency and streamlined processes. We wanted to share this framework as it is based on Maetrics’ collective experience supporting organisations to manage their regulatory requirements during this time.
“What we have learnt is that the more robust organisations are able to drive a flexible inhouse:outsource resource balance; any rapid changes in their circumstances means that they have support across a variety of product, geographic and specialist regulatory knowledge bases, to deploy when it is most needed, reducing risk for your organisation. Scalability and flexibility is the key to regulatory and quality compliance in the new normal. We have included a checklist to assess how well companies are positioned to meet current and future regulatory obligations and hope this will provide value in the re-evaluation process.”
