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.
- 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
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!
-21 CFR Part 11 Compliant and Validated
-Professionally Maintained and Updated
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.
Our team will provide a template to map prior e-subs to new granularity (eIND to eCTD, eNDA to eCTD, eBLA to eCTD, CTD to eCTD) and define your LCM (Lifecycle Management) process, enabling your company to establish relationships between documents from Legacy to New. We even provide an evaluation of resources including personnel, and tool comparison and selection.
MedXview can provide its highly skilled personnel for use on-site to complete your most challenging submission projects. Our consultants are leaders in their respective fields, possessing cutting-edge skills, creative problem-solving talents with complete thoroughness and efficiency in the completion of their projects. They are carefully selected professionals, determined to effectively fulfill your exact needs in the areas of data processing and presentation, regardless of your time constraints. Our software developers are experts in C++.NET, VB, JAVA, and SAS/ AF/STAT/GRAPH/SQL and more. Our Regulatory staff has worked on countless successful electronic submissions projects such as eIND’s, eBLA’s, eNDA’s, and eCTD’s. We can provide support in submission leaf file generation such as CRT datasets, data definition tables (define.pdf’s), and tables, listings, and graphs. We have outstanding statistical analysis experience and can bridge the gap that sometimes exists between the biostatistics group and regulatory affairs
SPL Conversion Services PLR and Drug Registration Certified
In an effort to help clients meet their regulatory requirements, MedXview provides the service of converting current labeling content into the required SPL format, with PLR Compliance and Drug Registration and Lisiting. Our professional services team eliminates the need for you to hire and train additional personnel or implement and maintain software solutions. This approach allows you to focus on more pressing regulatory duties.
MedXview begins using your completed Microsoft Word Documents as source documents for SPL conversion. We can also create a new MS Word Document from archived/historical/printed labeling content. Clients receive notification of project completion and receive electronic copies of the valid SPL deliverables. These deliverables can then be sent directly to the FDA for proper review. Our consulting staff can also help to fill the gap, providing valuable SPL education for your team so that in time you can handle SPL creation in-house.Our clients has experienced the greatest return on investment when taking a dual approach, simultaneously taking advantage of our valuable software solutions and professional services.
The FDA mandates the filing of product labeling information in the SPL (Structured Product Labeling) format. Many pharmaceutical developers, therefore, have determined the need for a reliable service provider that will enable the company to meet regulatory compliance guidelines without straining current business practices. MedXview will conveniently utilize your current labeling content and transform this readily available content into the required SPL R4 or Physician’s Labeling Rule Compliant format.
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