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Mark J.
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Starodub BV is a team of experts in regulatory affairs. We provide 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. Support is offered from early development to late commercialization. Starodub BV offers support with strategic decision making process, management of individual and multiple interrelated projects, and supervision of regulatory, quality and production teams. Our capability to provide strategic input, and to apply macro and micro project and people management techniques gives the possibility...
Regulatory affairs,cmc,post approval submissions,new submissions,project management,compliance,medical devices,small molecules,clinical trial applications,biotech,dossier due diligence,scientific advice,regulatory strategy,combination products,qms/iso,and ectd
Starodub bv operates in the Pharmaceutical manufacturing industry.
Starodub bv's revenue is 11m - 100m
Starodub bv has 11 - 50 employees.
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