We’re delighted to announce the appointment of Wendy Cook as a Qualified Person (QP) to further strengthen our regulatory and quality leadership team.
Wendy brings more than 20 years of pharmaceutical quality assurance experience across GLP, GCP and GMP environments, with experience in sterile manufacturing and clinical trial supply chains. Since qualifying as a QP in 2018, she has held roles at both CDMOs and global CMOs, where she oversaw batch certification, regulatory submissions and quality oversight across multiple dosage forms including sterile injectables.
Commenting on her appointment, Wendy said:
“Symbiosis has built a reputation for excellence in sterile manufacturing and regulatory compliance. I look forward to supporting clients in bringing their innovative therapies to patients quickly, safely and in full compliance with GMP.”
The appointment follows Symbiosis’ successful MHRA inspection of our new 20,000 sq ft GMP facility, which recently added a state-of-the-art automated sterile fill/finish line to our commercial capabilities. This latest regulatory milestone reinforces the businesses robust compliance track record with both the MHRA and FDA.
Nicola Paterson, Lead QP at Symbiosis, said:
“Wendy’s appointment strengthens our QP team at a pivotal time for Symbiosis. Her knowledge of GMP, regulatory expectations and sterile manufacturing adds significant expertise to our quality leadership. Combined with our recent regulatory approvals, Wendy’s arrival underlines our commitment to delivering world-class regulatory support and compliant, flexible access to sterile manufacturing capacity for our clients
In expanding our QP and quality leadership team, we continue to enhance our ability to help global biopharmaceutical companies navigate complex regulatory requirements while ensuring the reliable, timely delivery of life-saving injectable therapies.
