Eliquent provides life sciences organizations with consulting, training, and audit support to achieve compliance with US FDA and global regulations.

Performed audits and Mock Pre-Approval inspections of sterile and non-sterile pharmaceutical, biologic, biotech and device manufacturing and laboratory facilities. Developed and implemented client quality systems/programs: perform gap analyses comparing the current state of systems and programs to desired state requirements including cGMPs, GLPs, GCLPs, GCPs and best industry practices; performed verification audits to ensure corrective actions have been appropriately implemented; and generated and implemented policies, procedures, and other program documents. Project Management. Performed Data Integrity Assessments. Trainer for Quality Systems, deviation and OOS investigations. Regulatory filing gap assessments against current manufacturing and validation activities. Regulatory Submissions including Labeling, Drug Master Files, Annual Reports, & General Correspondence.

Oversaw information system development, validation, and implementation efforts for $120 million ISO 9002 certified, publicly traded pharmaceutical company. Facilitated validation and implementation of new and upgraded computer software including: P2K Plasma Center Module donor management, OASIS Sales and Information management, and Medusa 2000 laboratory information management systems. Coordinated compliance audits from regulatory and standardization bodies including German Health Authority, CLIA, and ISO resulting in a smooth audit, no critical observations, and renewal of certifications. Trained 25 staff in applicable

Actively managed and directed regulatory affairs/quality control/quality assurance departments for $20 million privately held pharmaceutical company. Personally have prepared all aspects of regulatory licensing documents including: IND, PLA, ELA, 510(k), DMF, ANADA, Veterinary Biologics Outline for Production, and labeling documents including documents submitted to DDMAC. Prepared documentation leading to eight newly licensed products, licensing of a new facility and licensing of a new water for injection (WFI) system. Prepared, submitted and maintained all annual facility and product registrations.Facilitated establishment inspections with the following regulatory agencies: CBER, ORA, Team Biologics, CDRH, USDA, DEA, HPB, and state agencies resulting in renewal or issuance of licenses. Managed 25-member quality control department which achieved over 100 days in a row of consistent measured quality performance. Facilitated implementation of new water for injection (WFI) system from initial testing through validation and license approval. Regulatory and Quality Responsibilities for Biosafety level 3 manufacturing and testing facility.