Medical Writing Services for Drug Development & Clinical Trials

  • Pre-IND, NDA, BLA authorship, compilation, correspondence and submission to the FDA of the United States
  • 505(b)(2) authorship, compilation, correspondence and submission to the FDA
  • Writing the clinical modules as per CTD
  • Writing high scientific quality clinical study protocol, Investigator’s Brochure (IB), Clinical Study Report (CSR), Patient Information Sheet & Informed Consent Form (PIS/ICF), etc.
  • Consult to the sponsors on planning non-clinical and clinical development plans