Anca Gospei

I am a pharmacist with three years of experience in clinical trials, combining direct scientific expertise in pharmacokinetic analysis and trial design with regulatory affairs and medical writing.

I author and contribute to clinical and regulatory documentation including protocols, informed consent forms, IMPDs, IBs and CSRs, ensuring compliance with ICH-GCP and EU CTD requirements.

I design PK analysis plans, conduct non-compartmental PK analyses using Phoenix WinNonlin, and have completed PK analyses for submissions to EU, FDA and ANVISA authorities; I have coordinated and submitted over 20 CTAs via the CTIS platform.

I ensure regulatory compliance for investigational medicinal products, liaise with cross-functional teams (regulatory, biostatistics, clinical ops, QA), and bring strong attention to detail, adaptability, and a commitment to continuous professional learning.