Operations: Regulatory Submittals and Services

Synchrogenix Regulatory Submission and Publishing Services

The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the flexibility to allocate resources to other projects.

Synchrogenix, through its GlobalSubmit technology, is a leader in this area, providing:

  • Regulatory submission and publishing services for investigational, pre-marketing, and marketing applications
  • Subsequent lifecycle maintenance submissions (amendments, supplements, and reports)
  • Drug Master File (DMF) submissions
  • Paper to electronic format conversions
  • US Agent services

The depth of our experience and knowledge acquired from our work with the US FDA, ICH, HL7 and industry groups is made available to our clients.

Our dedicated Regulatory Services publishing teams:

  • Guide your organization through compilation of an original submission
  • Perform submission maintenance
  • Scale up to meet changing requirements and timelines
  • Provide best practices training
  • Offer extended working hours due to regional office locations on US East and West coasts

Synchrogenix ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Through experience, expertise, and industry insight, Synchrogenix quickly responds to changes in global regulatory requirements and mandates, thus avoiding common issues that can lead to rejections.

Synchrogenix GlobalSubmit Submissions Management Suite

Synchrogenix offers the software solutions that regulatory operations professionals need to efficiently publish, validate, and review electronic common technical document (eCTD) submissions, plus COMMUNICATE and MANAGE, solutions to tie submissions to the bigger picture of regulatory information management.

When integrated with Synchrogenix’s GlobalSubmit Registration Management and Document Management suites, we offer the first truly integrated Regulatory Information Management (RIM) solution for the life sciences industry that supports the real world work habits of regulatory professionals. The fully integrated suite of products allows for informed scheduling and on-time delivery of regulatory submissions to health agencies worldwide.

Design of the Submissions Management suite eliminates a number of manual, time-intensive steps in the regulatory submission process and fortifies the trustworthiness of the data reported by the system.

Our software:

  • GlobalSubmit PUBLISH – Efficient PDF document publishing and QC
  • GlobalSubmit REVIEW – Submissions from the US FDA point of view
  • GlobalSubmit VALIDATE – Eliminate the risk of rejection
  • GlobalSubmit CROSSCHECK – A better way to verify bookmarks and hyperlinks
  • GlobalSubmit LINK – Break free from the limitations of Adobe Acrobat and plug-ins
  • GlobalSubmit WebReview – Simplified submission review for a complex regulatory world
  • GlobalSubmit COMMUNICATE – A central system to track agency correspondence and commitment
  • GlobalSubmit MANAGE – A central system to track submission data and regulatory activity status

    For more information on Synchrogenix services, please visit synchrogenix.com