Symbiosis Pharmaceutical Services has appointed Wendy Cook as a qualified person (QP), strengthening its regulatory and quality leadership team at a time of growth for the global contract manufacturing organisation (CMO). Symbiosis specialises in the sterile manufacture of injectable drug products.

Cook brings more than 20 years of pharmaceutical quality assurance experience across GLP, GCP and GMP environments, with expertise 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, overseeing batch certification, regulatory submissions and quality oversight across multiple dosage forms, including sterile injectables.

Commenting on her appointment, Cook 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 inspection by the MHRA of its new 20,000 sq ft GMP facility. The site recently added a state-of-the-art automated sterile fill/finish line to its commercial capabilities, reinforcing the company’s robust compliance record with both UK and US regulators.

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.”

By expanding its QP and quality leadership team, Symbiosis said it is further enhancing its ability to help global biopharmaceutical companies navigate complex regulatory requirements while ensuring the reliable and timely delivery of injectable therapies. The addition of Cook comes as demand for sterile manufacturing capacity continues to grow, particularly for therapies addressing critical or rare conditions where quality and compliance are essential.

Symbiosis said its strengthened quality leadership team, combined with its upgraded manufacturing facility, positions the company to provide clients with enhanced regulatory guidance, rapid batch certification and flexible manufacturing solutions for both clinical and commercial supply.