Medical device and Pharmaceutical Expertise

Starodub BV is a team of expert consultants in Regulatory Affairs, Quality, Operations & Improvement. We provide regulatory support for a wide variety of products: Small Molecules, Biotech/Biologics, Vaccines, Medical Devices, in vitro Diagnostic 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. We combine deep pharmaceutical expertise with a structured improvement approach, bringing focus, structure, and execution to quality and production environments. Our method builds on hands-on GMP experience and proven Lean, Six Sigma, and change management tools. We offer 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 to our clients to maintain regular life-cycle of products and at the same time execute changes quickly and efficiently. Starodub BV is qualified as SME (Small and Medium-sized Enterprises) in the EU, which can provide our clients with administrative, regulatory and financial benefits, e.g. reduced fees and easy access to EMA support. Besides EU regulatory support, we support submissions worldwide. We offer multilingual and multicultural support for clients desiring to expand their presence on other markets or requiring to work with other cultures. We are fluent in English, Dutch, Russian, Ukrainian and German. We operate in compliance with GxP regulations and ISO 9001/13485 standards. We care about our clients and patients they serve and we strive to provide the highest quality and efficiency to the assigned projects.