eSubmission Expertise Zone Expertise - eCTD / NeeS Strategy and Submission Expertise throughout the World - EUROPE - Centralised, Decentralised, Mutual Recognition, National - Expertise in Submission Types other than eCTD and NeeS Formats Procedures, CTA & IMPD - Expertise in submitting Baseline Dossiers, ICH E3 eCSR, ASMF and DMF - USA - IND, NDA, aNDA, BLA, IDE and PMA - Submission Portals: EMA Gateway, CESP; FDA & Health Canada Gateway - Swiss Medic - NDS Health Canada - Australia Project Management - ASEAN, GCC and Rest of the World - Planning, managing, tracking and ensuring on-time Published Dossier to meet Submission timelines Formatting - Provide advice to optimize Efficiency and Quality - Submission Formats and Publishing Specification updates - PDF ready for Submission - Publishing and Formatting on-site Trainings - Word Formatting for eCTD Compliant Conversion BlueReg experts Outsourcing Platform No matter how complex your requirements are, BlueReg exhelp you to design the appropriate support you need.perts can on Publishing & Submission Services “OPPUS” Publishing & Document Compliance Tools Publishing Tools & Expertise Document Compliance Tools & Expertise In all these activities, BlueReg will support - Publishing Tools - Adobe Acrobat DC you by • Extedo eCTD Manager - MS Word • I nsight Publisher - ISIToolbox - Providing a dedicated team of BlueReg consultants highly - Validators - PitStop Pro experienced in Publishing and Submission activities • Lorenz Validator - Quite Revealing • EURS Validator - Evermap - Ensuring project management oversight to maintain • I nsight Validator - Mapsoft consistency and high quality - Sharing with your company the BlueReg best practice guide and integration kit to make sure that all team members have Study Cases access to the same level of information - Putting in place a robust regulatory intelligence process PublishingProject Document Compliance Tools & Expertise to ensure compliance with worldwide Publishing and - Assign a Publishing Team - Assign a Document Compliance Team - Plan the publishing steps and timelines - Prepare the formatting step through Regulatory Submission requirements through meeting(s) with the teams meetings with client - Being involved at every stage of your projects: - Check and format the documentation - Format your documentation according • Formatting your documentation according to electronic - Publish in BlueReg or Client to Client/BlueReg requirements submission requirements environment - Double QC - Double QC and Validation according to - Transfer of the formatted • Ensuring publishing according to local needs Country/zone requirements documentation - Developing processes and KPIs for continuous monitoring - Transfer of the dossier + Validation - Lessons Learned Meetings Reports - Proposing a quality assurance plan and maintaining - Submission (If requested by client) adequate transition between all steps of the projects - Archiving (GED) - Lessons Learned Meeting