Experience in HPLC, GC, Dissolution, UV, TOC, and Sterility Testing. Hands-on expertise in analytical method development and validation. Aculife Healthcare
M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.
Works in close collaboration with the external service provider and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner.
Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.