Drug Safety

nonclinical      clinical      CMC      drug safety      clinical trial disclosure

Synchrogenix’s drug safety team offers the regulatory writing expertise and experience to provide you with high-quality drug safety/pharmacovigilance documents. Our team members are well-versed in ICH guidelines and knowledgeable of MedDRA, EudraVigilance, and signal detection and evaluation. We prepare the following documents for our clients.

  • PADERs, PSURs, ASRs/DSURs   Anita Allender Drug Safety
  • Narratives
  • SAE reports
  • ADRs
  • ISCRs/ASPRs
  • RMPs/REMSs
  • Health hazard evaluations
  • Risk minimization action plans
  • Risk assessments
  • Safety-efficacy reports
  • Clinical trials sections of CDSs
  • 505(b)(1) applications
  • 505(b)(2) applications
  • PDUFA filings
  • ANDAs
  • Reference safety information reviews/revisions (eg, core label, SPC, PI, CIB)