Menesa Consulting LLC

Menesa Consulting LLC provides RegOps services including business process definition, system implementation/adoption, and submission/document management. Regulatory Operations Services − Process evaluation, streamlining, and definition − SOPs, work instructions, job aids, checklists, and quick reference cards − Strategies for maximum re-use of documents and submission-readiness − System implementation and adoption considerations and strategies Regulatory Information Management (RIM) System Services − Veeva Vault RIM Business/System Administrator − System evaluation, implementation, maintenance, and enhancements − User requirements and solution development − Validation (script reviews, dry runs, and UAT execution from business perspective) − Development of training plans, materials, and tools including eLearning modules − Instructor-led training sessions and tracking training requirements − Migration planning and execution/support − User adoption and support − Reports and dashboards Submission/Document Management Services − Submission record, content plan, and/or binder creation and management − Document submission preparation/readiness (formatting, navigation, PDF renditions) − Driving document workflows for authoring, reviews and approvals − PDF compilations − Styles and templates