Communicate with Confidence

Strategic Writing and Compliance is Key to Successful Drug Development

With over 250 full-time employees in 17 global locations, Synchrogenix is one of the largest regulatory and medical writing groups in the industry. As a trusted and agile partner we provide all the benefits of in-house regulatory writers, but with the added experience and perspective of industry insiders — without the increased overhead. 

Regulatory Writing Services

Synchrogenix has expertise across all functional areas. Our team is highly skilled in managing the transition from pre-clinical to clinical trials and development, including Chemistry Manufacturing and Controls (CMC), through submission and approval, and on to post-marketing safety writing.

  • Product Development Plans
  • Investigational and Marketing Submission Documents
    • Administrative
    • CMC
    • Nonclinical
    • Clinical
  • Clinical Study Protocols and Reports
  • Patient Narratives
  • Regulatory Responses and Communications
  • Risk Management Plans
  • Drug Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)

Synchrogenix's Proven Record of Success