Medical Affairs & Regulatory Science

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.
Symyoo’s medical affairs and regulatory science (MA & RA) 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 MA & RS team has also full competence in medical affairs covering activities of advice and support with drug development and study start-up consultation. Our end-to-end expertise provides a blueprint to the successful MFDS/FDA/EMA approval for your drug, biologic and medical device development

Scientific Planning & Medical Writing Services

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

Regulatory Affair Services

• Gap analysis
• Regulatory filing (IND: Investigational New Drug) and follow-up
• Evaluating the best regulatory path (Fast track, Breakthrough therapy , Accelerated approval, Priority review, Orphan drug designation) for applications
• Regulatory meeting support and representation