Tim Kapsala works with EAS pharmaceutical clients to identify compliance gaps and deficiencies through audits and mock-FDA inspections, preparing reports documenting significant observations and providing recommendations to be used in remediation activities. Additionally, he performs mock FDA pre-approval audits prior to NDA and ANDA submissions, with audit capabilities including APIs, OTCs, pre-filled syringe biosimilars, due diligence, internal audit evaluation, pre-inspection readiness, distributor/vendor qualification, contract laboratory, contract manufacturer, and more.
Posted in Who’s Who at EAS.