1125 Boone Aire Road,
Florence, KY 41042
Call (859) 426-5035

Medical Writing Services

LBR staff has extensive medical writing experience including Pre-Clinical and Clinical Study Reports, INDs, Fast Track Applications, Orphan Drug Applications, BLAs, BLA and NDA overall and clinical summaries for Safety and Efficacy, CMC sections, CTD and eCTD submission format. The writing experience includes therapeutic areas of pain (general and arthritis/osteoporosis), HIV, Small Pox vaccine, cancer (prostate, lymphoma, brain, ovarian and small cell lung), contraceptive agents (hormonal and barrier), and veterinary reproductive agents.

LBR Medical Writing provides the following services:

  • Preclinical reports
  • Clinical reports (Phase 2 - 4)
  • Investigator's Brochure and updates
  • Regulatory submissions (eCTD, IND, NDA, INAD, NADA, BLA, CTA)
  • Expert Reports
  • Product Dossiers
  • Safety Narratives
  • Protocols
  • SOPs
  • Package Inserts
  • Labeling