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