Parexel’s regulatory experts will partner with life sciences companies to help ensure business continuity by analyzing manufacturing operations to reduce the risk of viral contamination. The four-step methodology, including risk assessment, development of a risk mitigation action plan, implementation of solutions and routine re-assessment, aims to ensure companies are supported over time and as circumstances change or new risks arise.
Parexel will leverage its experience in mitigating viral transmission cross contamination gained from experience at global health authorities, including MHRA’s Inspection, Enforcement and Standards Division and FDA/CDER’s Office of Pharmaceutical Quality, Office of Process and Facilities. The company’s Regulatory & Access team includes more than 1,000 on-staff consultants worldwide, including 80+ former regulators and inspectors who have extensive knowledge of GxP, CMC and cGMP review and inspections.
“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.”