ESI’s regulatory group for pharmaceutical and medical devices includes experienced employees, both ex-FDA and former industry professionals, who provide comprehensive assistance through the manufacturing timeline, from pre-submission of pharmaceutical NDA/ANDA and medical device 510(k), to manufacturing, packaging, and testing.
Our goal is to provide quality team support for regulatory issues so that our clients can maintain good manufacturing practices (GMP), while gaining efficiency in manufacturing. ESI uses a multidisciplinary team of regulatory professionals, scientists, and engineers to accomplish that goal - a team that can assist the quality unit, while solving and answering technical problems in manufacturing, laboratory, and packaging. ESI also provides assistance and analysis of vendor materials and materials supply chain.
ESI offers assistance through FDA compliance audits or through larger scope FDA 483 remediation activities. The ESI team has assisted manufacturers through FDA responses by providing audits, data review, writing investigations, investigation mentoring, performing root cause analysis, gap assessments of STP/SOP and validation packages, and reviewing laboratory, manufacturing, and biologic quality control and quality assurance systems. ESI’s laboratories also offer assistance in identifying unknown foreign material and particulate identification.
ESI's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.Find an Expert Contact Us