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 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, Polish, German and Chinese.
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.
Visit us @ https://www.starodub.nl/en
Company Details
- Employees
- 17
- Founded
- -
- Address
- Industriestraat 14, Nuland,5391 Br,netherlands
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- starodub.nl
- Keywords
- 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, eCTD.
- HQ
- Nuland
Starodub Bv Questions
Starodub Bv's website is starodub.nl
Starodub Bv's LinkedIn profile is https://nl.linkedin.com/company/starodub-bv
Starodub Bv has
17 employees.
View email and phone details for 17
employees at Starodub Bv.
Starodub Bv's industry is
Pharmaceutical Manufacturing
Starodub Bv's top competitors are
Genmab,
College Ter Beoordeling Van Geneesmiddelen,
Laboratorios Biopas,
Dutch Association For Pharmaceutical Medicine,
Interdos,
Msd Netherlands,
Byondis,
Brb St Kimyasal As.,
Delpharm,
Dada Consultancy B.v..
Starodub Bv's categories are Pharmaceutical Manufacturing
Starodub Bv's founding year is 2014
