"Not only did Magellan do such a thorough gap analysis of our quality system, they provided our regulatory and quality systems team with the roadmap to addressing our deficiencies to help us ensure we are compliant, prior to the FDA’s audit. They made some great catches as they critically reviewed more than 200 SOPs and even provided a solid, implementable recommendation on how to better organize the system which won’t require a great deal of work for us.”
VP of Regulatory - Biologic/Tissue Company
Our Regulatory Compliance teams are comprised of seasoned professionals who have previously worked as:
Director of Regulatory Affairs, Regulatory Affairs Managers, Regulatory Compliance Specialists, Quality Systems Managers, Biostatisticians, to name a few.
Our Integrated Business Units