Author, review and execute validation deliverables, including validation plans, user and functional requirements, risk assessments, IQ/OQ/PQ (Installation, Operational and Performance Qualification) protocols, traceability matrices and validation summary reports, in line with GAMP 5 (Good Automated Manufacturing Practice), Second Edition. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder.