Assuring Regulatory Success with Customized Submission Support that Accelerates and Anticipates

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

Want to learn more about how we can help assure your regulatory success? Contact us today.

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Anticipating Challenges Helps Accelerate Submissions & Mitigates Risk of Costly Delays

  • Proactive management of project timelines
  • Deep regulatory knowledge enables 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


Services

Synchrogenix supports sponsor submissions to all major global agencies. 

  • Investigational and marketing application submissions
  • Lifecycle maintenance submissions
  • Master file submissions
  • Dossier management
  • U.S. agent services
  • Electronic transmission
  • Regulatory affairs

GlobalSubmit eCTD Submissions Management Software

  • PUBLISH for more efficient PDF document publishing and QC | Learn more
  • VALIDATE for assessing the technical validity of your submissions | Learn more
  • WebReview for simplified anytime, anywhere submission review | Learn more

Contact our submissions specialists today.

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