Our People And Our Expertise
I have a PhD in Medical Sciences and I am a Medical Biologist by training. I have a broad knowledge of Regulatory Affairs with about 10 years of experience in a global setting. I have been the RA global project lead for submission strategies, health authority communications (pre-submission/scientific-advise meetings; FDA, EMA, National) and product-lifecycle management, including work-sharing, grouped and single variations. I am trained on GCP, GMP, QM (ISO 9001/13485) and auditing.
Additionally I am experienced in application of Risk Management (ISO 14971), Management Review, Clinical Evaluation (ISO 14155) and other Regulatory requirements for Medical Devices and Combination Products (CE-marking, 510k, labeling).
My specialty is RA project management, scientific advice, medical device/combination products, submissions and labeling.
At STARoDub BV I appreciate next to the professionalism combined with flexibility and variety, the client-oriented teamwork intended to bring the output of high quality and efficiency.