What can we do for you?
Our team has over 35 years of proven expertise in toxicological risk assessment of a drug. Based on existing data from non-clinical studies, clinical trials, literature reviews, and similar compounds, we support in identifying and characterizing potential hazards of a drug. Throughout the processes of Dose-Response Assessment, Exposure Assessment, Risk Characterization, our experts ensure that the safety profile of your drug is understood.
We support in safety/risk assessments in the context of CTD module 2.4 submissions, IMPD/IND’s and for specific issues in e.g. genotoxicity, carcinogenicity.
Contact us today 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.
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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.