Mitigate risk of costly delays

Ensure efficient, timely submissions through software and services that break down barriers between strategy, dossier development and global transmissions. Avoid common issues that can lead to rejections by partnering with an experienced partner whose ability to quickly respond to changes in global regulatory requirements and mandates, keeps your submissions on track.

Accelerate submission success with unrivaled expertise, advanced technology and round-the-clock operational flexibility.

We collaborate closely with our partners to achieve your regulatory milestones.  Here is what our clients say:

“We’ve have very tight, and often changing, schedules for submissions – our team at Synchrogenix has been extremely responsive and creative to meet our needs..” – Chief Compliance Officer at biotech company

“They are a delight to work with and make the process seamless.  They are always there to support us when we have questions and are very timely with responses.”  – Senior Regulatory Affairs Manager at a biotech company

“Excellent subject matter expertise, customer service, responsiveness and flexibility. A pleasure to work with the entire team.” – VP of Regulatory Science at Japan-based company

Anticipate challenges early to accelerate submissions
  • Deep regulatory knowledge, enabling fast responses to changed regulatory requirements and mandates
  • Proven track record in rare/orphan diseases and gene therapy
  • Flexibility to meet changing requirements and timelines
  • Simplified submission review
  • Proactive management of project timelines
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All the support you need, anytime and anywhere
  • Investigational and marketing application submissions
  • Lifecycle maintenance submissions
  • Master file submissions
  • Dossier management
  • S. agent services
  • Electronic transmission
  • Regulatory affairs

“Working with Synchrogenix was the next best thing to having a fully staffed and seasoned RegOps team on site.” – Vice President of Regulatory Affairs at Gritstone Oncology

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GlobalSubmit eCTD Submissions Management Software
  • Use GlobalSubmit PUBLISH for more efficient PDF document publishing and QC
  • GlobalSubmit VALIDATE helps to assess the technical validity of your submissions
  • WebReview is your first choice for streamlined submission review, anytime and anywhere
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