Protocol Development & Medical Writing

At Synergen Bio, we combine therapeutic expertise with strategic regulatory insight to strengthen every stage of your drug development program. From protocol design and medical monitoring to final study reports, publications, and submissions, we help optimize your product’s path to approval.

Protocol & Study Design Support:

  • Literature reviews
  • Study design and protocol development
  • Informed Consent Form (ICF) development
  • Case Report Form (CRF) design
  • Toxicological risk assessments (PDE)
  • Therapeutic area consulting
  • Clinical trial monitoring documentation Investigator brochure & Product Monograph
  • Therapeutic area consulting
  • Scientific and medical support & training for project teams and sites

Medical Writing & Publications:

  • Clinical study reports (CSR)
  • Investigator brochures, product monographs, and IMPDs
  • eCTD-compliant study reports with hyperlinking & bookmarking
  • FDA Summary Tables for ANDA submissions
  • Clinical Summary of Bioequivalence (CS-BE) for TPD submissions
  • Manuscripts, abstracts, and conference posters
  • Educational materials for patients, HCPs, and industry personnel
  • Literature reviews and publication planning
  • Medical marketing reviews and reports