Company to leverage global pandemic expertise along with cGMP inspection and CMC review experience from former global health authority leaders to help companies ensure an uninterrupted supply of pharmaceutical and device products essential for public health

BOSTON and DURHAM, N.C., May 11, 2020 (GLOBE NEWSWIRE) -- Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health, from Clinical through Commercialization, today 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 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.”

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.

About Parexel

Parexel is focused on supporting the development of innovative new therapies to improve patient health. During the COVID-19 crisis, we continue to be committed to our customers’ business while putting the safety of patients, client partners and our employees at the heart of everything we do. To learn more about our efforts related to COVID-19, as well as the experts, innovations and processes we have in

place to navigate the rapidly changing landscape, visit our website and follow us on LinkedIn, Twitter and Instagram.

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

Parexel Contacts:
Media:

Wendy Ryan, Parexel
Wendy.ryan@parexel.com

Kathryn McMahon Arrigg, PAN Communications
Tel.: +1 617-502-4300
Email: PAREXEL@pancomm.com