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 presubmission
of pharmaceutical NDA/ANDA and medical device 510(k), to manufacturing, packaging and testing.
The ESI goal is to provide manufacturing quality teams support for regulatory issues so that our client 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,
mentoring on investigations, 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 offers assistance in identifying unkown foreign material and particulate identification.