Valentyna Starodub and Erwin Waas
Valentyna Starodub, CEO, STARoDub
I have more than 16 years of experience in the Pharmaceutical industry. In my previous jobs both in the Netherlands and Ireland, with world-wide leading pharmaceutical companies, I led teams of Regulatory professionals. I hold a Ph.D. in biotechnology I and have a broad experience in regulatory CMC. I am fluent in English, Dutch, Ukrainian and Russian. My specialism is strategic regulatory decision making for large projects, during acquisitions and mergers. In the current role as CEO of Starodub I lead a team of regulatory experts supporting small and large companies with regulatory activities related to small, large molecules, medical devices, combination products and eCTD.
Erwin Waas, Senior Regulatory Affairs Manager, STARoDub
At STARoDub B.V. I work for a variety of customers seeking regulatory and quality support for their products and organizational setup. I have been trained on ISO 13485 Quality Management for Medical Devices by TUV, as well as for ISO 14971 Risk Management. I have contacts at Notified Bodies and work also for pharmaceutical industry clients that seek combination product expertise. My specialism is customer satisfaction in the area of medical device support, providing regulatory strategy for new or existing products, including the setup of a complete technical file that fulfills the relevant essential requirements for quality and safety. Look me up, I like to exchange ideas.
Keywords: Regulatory Affairs, Medical Device Support
STARoDub is a team of experts in regulatory affairs. We provide worldwide regulatory support for a wide variety of products: Small Molecules, Biotech/Biologics, Vaccines, Medical Devices and Combination Products. We have extensive expertise in Chemistry, Manufacturing and Controls, regulatory operations including eCTD, pre-clinical and clinical regulatory affairs.
We care about our clients and patients they serve and we strive to provide the highest quality and efficiency to the assigned projects. We can be your companion to liaise with regulatory agencies worldwide and provide you with benefits of our qualification as SME (Small and Medium-sized Enterprises) in the EU.