What can we do for you?
We offer comprehensive support in designing your non-clinical development strategy and program to maximize the likelihood of moving your drug candidates into the clinic (CTA/IND) and onto the market (MAA/BLA/NDA).
Our experts focus on the optimum program of relevant in vitro and/or in vivo non-clinical studies necessary to start early clinical trials, thus making the most efficient use of your time, resources and money.
Our team ensures that your non-clinical development strategy and program meet the scientific and regulatory requirements defined by the EU, US, UK and other regulatory authorities, paving the way for smooth approval processes.
Contact us to discuss how our tailored approach can support your regulatory requirements and advance your research objectives. Together, let’s shape the future of safer and more effective therapies.
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
Questions from our clients
FAQ Section
A successful non-clinical program hinges on a scientifically sound strategy and meticulous execution. This requires selecting the most appropriate in vitro and in vivo models, designing studies with dose ranges and routes relevant to clinical use, and generating data that comprehensively assesses preclinical efficacy and safety and guides safe dosing in humans. Our expertise helps you navigate these critical steps, ensuring your program meets scientific and regulatory requirements and lays the groundwork for successful clinical development.