Medical Affairs & Writing

We fully understand that research results, product use, and other medical information should be clearly and concisely written and this well-structured documentation plays a major role, especially in the approval process for drugs, devices and biologics.

Our Medical Affairs Team is comprised of medical experts with unparalleled project experience related to marketing authorization procedures and clinical trial applications in addition to common technical document (CTD) writing.

Symyoo’s Medical Affairs Team has also full competence in various clinical activities and collaboration with the clinical investigators and sponsors in the development of the protocol and study start-up consultation. Prior to the study initiation, the Medical Affairs Team prepares study information for use by internal delegation team through literature and clinical background review.

  • Consultation on Drug Development
  • Literature and clinical background review
  • Study protocol and synopsis development, amendments, and administrative changes for
    • Phase I, II, III Trial
    • Non-Interventional / Observational Study
    • Registry Study
    • Post-Authorization Safety Study
    • Epidemiologic Study etc.
  • Informed Consent, investigator Brochure, participant study information sheet, and other study materials
  • Patient narratives
  • Regulatory agency and IRB submissions
  • Common Technical Document (CTD) Writing