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
Company Details
- Address
- Klosterneuburger Straße, 15,austria
- Industry
- It Services And It Consulting
- NAICS
-
Computer Systems Design and Related ServicesOther Computer Related Services
- Keywords
- eCTD, eSubmission, SPL, xEVMPD, IDMP, NeeS, RIM, RPA, Computer System Validation, Process Optimization, CESP, eAF, Submission Standards, eCTD Validation, User Training, EDMS, ESG, Submission Viewer, ISI Toolbox, Submission Template, SharePoint, Submission Archive, Business Process Automation (BPA), End User Support, Data Standardization, Regulatory Data Management Tracking, Data collection, analysis, standardization, migration and QC, Document & Submission Level Publishing, SPOR/IDMP readiness and support, User Requirement definition, UAT, eASMF, ePMF, PSUR Repository, eCTD v4.0, RPS, SPOR, eSignatures, Paediatric Submissions, PAM Submission, eSubmission Gateway, CESSP Dataset Module, SPOR, Web Trader, AdPromo, CE Marking, Technical Device Dossier, Submission Lifecyle Management, EDQM CEP, System Validaiton, eCTD Convertion.
- HQ
- Vienna
- Competitors
- Covigilance, monkeys Business Web Solutions, UX Design Services für Web, App, Software | ClemensW, AUXILIUM … Web- & Werbeagentur, TOPRA - The Organisation for Professionals in Regulatory Affairs, nTrack, HWS - Haikal Web Solutions, udm Web Solutions GmbH, Winged Web, BRANDIANA — Web Design & Branding.
Regorbit Questions
Regorbit's LinkedIn profile is https://at.linkedin.com/company/regorbit
Regorbit's industry is
IT Services and IT Consulting
Regorbit's top competitors are
Covigilance,
Monkeys Business Web Solutions,
Ux Design Services Für Web, App, Software | Clemensw,
Auxilium … Web- & Werbeagentur,
Topra - The Organisation For Professionals In Regulatory Affairs,
Ntrack,
Hws - Haikal Web Solutions,
Udm Web Solutions Gmbh,
Winged Web,
Brandiana — Web Design & Branding.
Regorbit's categories are IT Services and IT Consulting
