Parexel unveiled its COVID-19 Risk Mitigation offering, which leverages the company’s experience with global viral outbreaks as well as cGMP inspection and CMC review processes to ensure that manufacturers can safely and confidently continue operations through the COVID-19 pandemic.
“COVID-19 has impacted just about every aspect of drug development and manufacturing, yet at the same time we must deliver on our promises to the patients who are awaiting new therapies every day,” said Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer. “Safely and successfully ensuring an uninterrupted supply of pharmaceutical and device products will be key to maintaining the development and delivery of new medicines for patients throughout the pandemic.”
Parexel’s regulatory experts will partner with life sciences companies to ensure business continuity during these challenging times by rigorously analyzing manufacturing operations to reduce the risk of viral contamination. This will be accomplished through a four-step methodology, including risk assessment, development of a risk mitigation action plan, implementation of solutions and routine re-assessment to ensure companies are supported over time and as circumstances change or new risks arise.
“While there is still much that is unknown about COVID-19, we do have well-established and tested processes accepted by global health authorities to guide us as we move forward during these uncertain times,” said Lynne Ensor, Vice President, Regulatory, Parexel and former Acting Deputy Director of the FDA Office of Process and Facilities in the Office of Pharmaceutical Quality/CDER. “Drawing on this experience and expertise and deploying it in a methodical and rigorous way will support long-term safety in our manufacturing facilities and productivity for our industry.”