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
