Regulatory Writing

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nonclinical      clinical      CMC      drug safety      clinical trial disclosure

By merging our cross-functional expertise with our writing experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability. We provide many of the benefits of in-house writers—including the experience and perspective of industry insiders—without increased overhead or struggles with fluctuating workloads.

Pharma Biotech Regulatory WritingSynchrogenix's team of 40+ writers and editors includes experts in nonclinical, clinical, CMC, and drug safety documents. Our writers also apply their expertise with clinical study reports to streamline the process of clinical trial registration and disclosure. The following documents are among those in Synchrogenix's fields of expertise.

Modules 1-5 QOS INDs/IMPDs PSURs/ASRs
Protocols IBs ICFs CSRs (Phase 1-4)
CRFs ISSs/ISEs CSSs/CSEs Briefing packages
Position papers          Regulatory responses          NDAs/MAAs          Orphan drug applications