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Exceptional Regulatory Submission Services

MedXview offers life science companies the best software solutions and top-notch regulatory submission services. Since we utilize our automated solutions, we can deliver exceptional results effectively and efficiently. We help clients resolve the unanticipated twists of daily eSubmission work and can provide these services on- and off-site.
By trusting MedXview to outsource your eSubmission projects, you can save considerable expense in equipment, space, training, and high-priced benefit packages for nonessential personnel. Along with dramatic reductions in project scope and budget, we deliver the complete submission package, from identifying the problems and formalizing the data structure to preparing the necessary documentation and providing a fully validated submission.
At MedXview, your satisfaction is our priority. Our work does not stop until we not only meet but also exceed your expectations.

Our Services Include:

  • Full IND, ANDA, and NDA Submission Outsourcing
  • Document Authoring and Medical Writing Services
  • CDISC Compliance Data Reporting, Analysis, and Publishing for eSubmissions
  • SPL Conversion
  • PDF Document Standardization and eSubmission Readiness
  • Legacy Document Conversion and Rendering
Our team will prepare a template to map prior e-subs to new granularity and define your LCM (Lifecycle Management) process, enabling your company to establish relationships between documents from a legacy to a new one. We will also provide an evaluation of resources, including personnel and tool comparison and selection.

Other Services

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MedXview has highly skilled staff ready to assist you on-site to complete your most challenging submission projects. Our consultants are experts in their fields, equipped with cutting-edge knowledge, innovative problem-solving skills, and a commitment to complete projects thoroughly and effectively. Regardless of time constraints, they are carefully chosen professionals dedicated to successfully meeting your precise data processing and presentation needs. We have outstanding statistical analysis experience and the capability to bridge the gap that exists between the biostatistics group and regulatory affairs.
SPL Conversion Services (PLR and Drug Registration Certified)
To help our 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 listing. Our team of professionals eliminates the need for you to hire and train additional personnel or implement and maintain software solutions. This integrated approach enables you to concentrate on more important regulatory obligations.

Training

Since 1998, MedXview has been helping organizations train their employees on workplace eSubmission. All of our online or ILT training courses are designed to comply with FDA, EMA, and the requirements of agencies worldwide. Our training programs include:
  • WebEx/Zoom Hands-On eCTD and CDISC Data Conversion Training
  • On-Site ILT eCTD Training
  • SPL Conversion Training
  • Laboratory Management Training
  • Content Management Training
Whether you are a Fortune 500 company in need of industrial eCTD or eSubmission training or an individual Regulatory Affairs Consultant needing to deliver eCTD training to a few users, we have a solution for you. Our eCTD training is affordable, available for everyone, and used by some of the largest companies worldwide.
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