Parexel, a provider of solutions to accelerate the development and delivery of therapies to improve world health, from Clinical through Commercialization, has unveiled its COVID-19 Risk Mitigation offering, which leverages the company’s significant experience with global viral outbreaks as well as cGMP inspection and CMC review processes so 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.
Parexel’s experts bring first-hand experience in mitigating viral transmission cross contamination gained from decades of 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 integrated Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, including 80+ Former regulators and inspectors who have extensive knowledge of and expertise with the GxP, CMC and cGMP review and inspections that companies must navigate successfully to ensure new therapies reach the patients who need them. For more information about Parexel’s COVID-19 Risk Assessment Offering and Parexel Regulatory & Access, as well as insights from regulatory and health authority experts, visit Parexel’s COVID-19 Resource Center.