RegOrbit

RegOrbit provides Regulatory Operation and electronic submissions (eCTD, NeeS, xEVMPD, SPL) services to the pharmaceutical Companies. RegOrbit team supports various Life Science companies to build, review & submit different types of electronic regulatory submissions to numerous Health Authorities across the globe on timely manner. Our experienced RegOrbit consultant supports to effectively select and implement Regulatory Information Management (RIM) systems & process optimization, authoring of user & functional requirements, system design, process development, validation documentations including qualification documentation, training and user training documentation, test scripts. RegOrbit experts help regulatory system integrations and/or upgrades and data migration activities and our experts act as a link between IT and business teams and translate your business requirements to IT language. RegOrbit assist companies with Regulatory data cleansing, data analytics and RIM Data standards, set up data governance and develop world class best practice RIM data definitions. Our RIM experts support global product registration tracking & reporting and offers XEVMPD support & IDMP data gap analysis and readiness assessments. If you wish to get in touch with a member of RegOrbit team, please contact us at Email : info@regorbit.com Telephone: +43 68110531332