Medxview Inc

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Description

MedXview : Services Professional Services: Unmatched Experience and Accelerated Knowledge Transfer MedXview not only provides the best-quality software solutions but also top-notch services for life science companies. Since we utilize our automated solutions we are able to provide reliable results in a fraction of the time and at a fraction of the cost usually incurred by outsourcing these regulatory concerns. We help clients resolve the unanticipated twists of daily e-Submission work and can provide expert services on-site and off. Our work does not stop until our clients are 100% satisfied. When outsourcing their e-submission projects to MedXview, our clients have saved extravagant costs in equipment, space, training, and high-priced benefit packages for nonessential personnel. Along with dramatic reductions in project scope and budget, MedXview delivers the COMPLETE submission package -- from identifying the problems and formalizing the data structure, to preparing the necessary documentation and delivering a fully validated submission. Services Include: - Full Submission Outsourcing - Document Authoring and Medical Writing Services - CDISC Compliance …Data Reporting, Analysis, and Publishing for eSubmissions - SPL Publishing (2a and PLR Compliance) - PDF Document Standardization and eSubmission Readiness - Legacy Document Conversion and Rendering eCentral SaaS Enlist our Software as a Service (SaaS) model and you will receive unmatched experience with accelerated knowledge transfer to get the job done right the first time! -Fully Hosted -21 CFR Part 11 Compliant and Validated -Professionally Maintained and Updated -Completely Secure MedXview will work with your team to define the project according to your exact specifications and provide the deliverables under even the most drastic time constraints. MedXview ’s staff uses proprietary software tools, which are fully validated to maintain 21 CFR Part 11 standards, enabling us to create and publish e-submissions in a fraction of the traditional time needed. Submission Readiness Assessment In order to reach a goal, first one must evaluate their current position. MedXview ’s experienced staff can help your team understand your current process, define your goal, and evaluate the changes needed to meet your goals, and do this all faster and with greater efficiency. MedXview remains informed of regulatory requirements through continuous contact with regulatory agencies : FDA, EU, Japan etc. We have taken part in numerous Pre-submission meetings and can help your team anticipate any changes that may take place to your current business practices to become e-submission ready. Our consultants will provide a Roadmap and Summary sheet. We will evaluate the scope of the guidance and perform comparisons for different regional requirements. We can help centralize and standardize your information, establishing company wide conventions for naming and storage of your data.

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