Expert Consultants

Reliable, Efficient, Knowledgeable Expert Consultants in Regulatory Affairs, Quality, Operations & Improvement Starodub consultants partner with (bio)pharmaceutical, medical device, and in vitro diagnostic companies to ensure that regulatory and GMP requirements are met and business goals are achieved. 18 (Bio) Pharmaceuticals We will support you in developing and registering your medicinal product(s), such as small molecules, biologics, biotechnology derived products, and vaccines Medical Devices We support the development and registration of your medical devices , such as class I to class III devices, including software, in vitro diagnostic and drug-device combination products worldwide Regulatory Operations To make sure that your application conforms with all other requirements beside the scientific requirements, we support regulatory operations and provide publishing services We support you with expert GMP guidance and proven Lean strategies to improve quality and operations, ensuring regulatory compliance and long-term process efficiency. Who are we? Starodub aims to be your strong and trusted partner when making strategic regulatory decisions Starodub was founded in May 2014. The company started with one employee, the founder Valentyna Starodub. By today, our team has grown to round 20 employees and has a valuable network of specialised experts. We partner with (bio)pharmaceutical and medical device companies worldwide to ensure that regulatory requirements are met and business goals, such as quick market access and compliance, are achieved. Read our whitepapers The Starodub team, provides key expertise for ATMPs in Discovery and Early Development Stage. Their core team of experts is highly effective crafting the right messages and in engaging with authorities in a very effective format. They have been pivotal to ensure success and enable to deliver the necessary inflection points for the CAR-T programs of ...