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
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
Regulatory agency and IRB submissions
Common Technical Document (CTD) Writing
Regulatory Affair Services
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